Clinical Trials in Cataract

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Article initiated by:
Francesc March de Ribot, MD, PhD
All contributors:
Leo A. Kim, MD, PhD, Derek W DelMonte, MD, Francesc March de Ribot, MD, PhD, Srishti Khullar
Assigned editor:
Mark P. Breazzano, MD, FACS
Review:
Assigned status Update Pending
.


Introduction

Cataract surgery is one of the most commonly performed and successful procedures worldwide. Over the past several decades, clinical trials have shaped nearly every aspect of cataract care, including timing of surgery, preoperative testing, surgical technique, intraocular lens selection, pediatric cataract management, postoperative endophthalmitis treatment, prevention of posterior capsule opacification, and visual rehabilitation.

Recent trials have also evaluated femtosecond laser-assisted cataract surgery, toric and presbyopia -correcting intraocular lenses, light-adjustable lenses, extended-depth-of-focus lenses, and artificial intelligence-assisted surgical planning.

Landmark Clinical Trials in Cataract Surgery

Endophthalmitis Prevention and Treatment

Endophthalmitis evidence is divided into the following:

  • Treatment trials, represented by the Endophthalmitis Vitrectomy Study, and
  • Prophylaxis trials, represented by the ESCRS Endophthalmitis Study.

Both remain central because endophthalmitis is rare but vision-threatening.

Endophthalmitis Vitrectomy Study (EVS)

  • The Endophthalmitis Vitrectomy Study is one of the most important landmark trials in cataract surgery because it provided evidence-based guidance for the management of acute postoperative endophthalmitis.
  • The trial evaluated immediate pars plana vitrectomy versus vitreous tap/biopsy and intravenous antibiotics versus no intravenous antibiotics.
  • The main clinical lesson was that immediate vitrectomy was most beneficial in eyes presenting with light perception vision, while routine intravenous antibiotics did not improve final visual outcomes when intravitreal antibiotics were used.
  • These findings continue to influence the initial management of acute postoperative endophthalmitis.[1][2]
  • Key findings of the this study are listed in Table 1.


Table 1. Endophthalmitis Vitrectomy Study (EVS)

Parameter Details
Year 1995
Objective To determine the role of immediate pars plana vitrectomy and systemic intravenous antibiotics in acute postoperative endophthalmitis after cataract surgery.
Population Patients with acute postoperative bacterial endophthalmitis after cataract surgery or secondary IOL implantation.
Design Multicenter randomised clinical trial; immediate vitrectomy vs vitreous tap/biopsy; IV antibiotics vs no IV antibiotics.
Main outcome Final visual acuity.
Key results Immediate vitrectomy was most beneficial in eyes presenting with light perception only. Routine systemic IV antibiotics did not improve the final visual outcome when intravitreal antibiotics were used.
Limitations Older surgical era; microbiology, antibiotics, vitrectomy technology, and cataract surgery techniques have changed.

Mainly applicable to acute post-cataract bacterial endophthalmitis.

ESCRS Endophthalmitis Study

  • The European Society of Cataract Surgery study shifted cataract prophylaxis toward intracameral antibiotics, especially Cefuroxime.[3]
  • Endophthalmitis prevention depends on safe drug preparation, correct dilution, allergy awareness, aseptic technique, wound construction, and local antimicrobial policy. The key parameters are listed in Table 2.

Table 2. ESCRS Endophthalmitis Study

Parameter Details
Year 2006-2007
Objective To evaluate whether intracameral cefuroxime reduces postoperative endophthalmitis after cataract surgery.
Population Patients undergoing cataract surgery in European centers.
Design Large multicenter randomized partially masked clinical trial.
Main outcome Rate of postoperative endophthalmitis.
Key results / impact Intracameral cefuroxime significantly reduced postoperative endophthalmitis risk and influenced prophylaxis practice in many regions.
Limitations Drug preparation, dose accuracy, allergy, local resistance patterns, and availability vary by region. Endophthalmitis is rare, requiring large sample sizes.

Pediatric cataract surgery trial

  • Pediatric cataract trials differ from adult trials because long-term visual outcome depends on surgery, optical correction, amblyopia therapy, glaucoma surveillance, parental adherence, and follow-up over the years.

Infant Aphakia Treatment Study

  • The trial showed that primary intraocular lens implantation in very young infants with unilateral congenital cataract does not confer superior visual outcomes compared with aphakic contact lens correction.
  • Primary IOL implantation was associated with a greater burden of adverse events and additional intraocular procedures.
  • The trial emphasises that pediatric cataract outcomes depend not only on the initial optical strategy but also on amblyopia therapy, refractive follow-up, parental adherence, and long-term surveillance[4][5][6]. Key findings of the this study are listed in Table 3.

.Table 3. Infant Aphakia Treatment Study (IATS)

Parameter Details
Year 2010 initial report;

2014 five-year outcome; later 10-year follow-up reports

Objective To compare primary IOL implantation with aphakic contact lens correction after unilateral congenital cataract surgery in infancy.
Population Infants with unilateral congenital cataract operated during early infancy.
Design Multicenter randomized controlled trial.
Main outcome Visual acuity, adverse events, and need for additional intraocular surgery.
Key results / impact Primary IOL implantation in very young infants did not clearly improve visual acuity compared with contact lens correction and was associated with more adverse events/additional surgery.
Limitations Applies mainly to unilateral infantile cataract. Outcomes depend on amblyopia therapy, refractive correction, parental compliance, and long-term follow-up.

Femtosecond Laser-Assisted Cataract Surgery (FLACS) Trials

  • Large randomised trials evaluating femtosecond laser-assisted cataract surgery have shown that greater technical precision does not consistently translate into superiority over well-performed conventional phacoemulsification in routine cataract surgery.
  • Although FLACS may improve capsulotomy and reduce phacoenergy in selected settings, major trials such as FEMCAT and FACT (Femtosecond laser-assisted cataract surgery versus Conventional Phacoemulsification) did not show sufficient routine clinical or economic advantage to justify universal adoption. Key findings of this study are listed in Tables 4 and 5.[7][8][9]
  • Low-energy FLACS platforms and trainee-focused FLACS studies should be presented as evolving evidence rather than established practice-changing evidence. (Table 6)
  • Recent meta-analyses suggest potential early advantages in endothelial parameters and phaco energy, but long-term visual superiority remains inconsistent.
  • In trainees, FLACS may standardise selected steps but cannot replace supervised manual skill acquisition.(Table 7)


Table 4 . FEMCAT Trial

Parameter Details
Year 2020
Objective To compare clinical and economic outcomes of femtosecond laser-assisted cataract surgery with conventional phacoemulsification.
Population Adults undergoing cataract surgery in a multicenter setting.
Design Multicenter participant-masked randomized superiority and cost-effectiveness trial.
Main outcome Treatment success, visual outcomes, safety, and cost utility.
Key results / impact FLACS did not provide sufficient additional clinical benefit to justify higher cost in routine cataract surgery.
Limitations Cost-effectiveness is setting-specific; results may change with newer platforms, reduced laser cost, or selected complex cases.

Table 5. FACT Trial

Parameter Details
Year 2020
Objective To compare femtosecond laser-assisted cataract surgery with conventional phacoemulsification.
Population Adults undergoing cataract surgery.
Design Randomized controlled non-inferiority trial.
Main outcome Uncorrected distance visual acuity, safety, patient-reported outcomes, and cost-effectiveness.
Key results / impact FLACS was not inferior to conventional phacoemulsification but did not show clear clinically meaningful superiority in routine cases.
Limitations Results may vary with surgeon experience, cataract density, laser platform, case complexity, and cost structure.

Table 6. Low-Energy Femtosecond Laser-Assisted Cataract Surgery (FLACS) Trial

Year 2020s
Objective To assess whether low-energy femtosecond laser platforms improve surgical or visual outcomes compared with conventional phacoemulsification.
Population Adults undergoing cataract surgery.
Design Randomized or prospective comparative studies.
Main outcome Visual acuity, refractive accuracy, endothelial cell loss, phaco energy, and complications.
Key results / impact Low-energy FLACS may reduce phaco energy and improve precision of some surgical steps, but consistent superiority in routine visual outcomes remains unproven.
Limitations Often small or single-center studies; outcomes depend on laser settings, cataract grade, and surgeon experience.

Table 7. FLACS in Training / Junior Surgeon Studies

Parameter Details
Year 2020s
Objective To determine whether FLACS improves safety or standardization when cataract surgery is performed by junior surgeons.
Population Cataract patients operated by trainees or junior surgeons.
Design Randomized or prospective comparative studies.
Main outcome Complication rate, visual outcome, surgical efficiency, and learning curve.
Key results / impact FLACS may standardize steps such as capsulotomy and lens fragmentation, but it does not replace supervised surgical training.
Limitations Training environment-dependent; generalizability depends on supervision, case selection, and institutional workflow.

Astigmatism Management Trials

  • Astigmatism trials should be interpreted with attention to posterior corneal astigmatism, surgically induced astigmatism, toric IOL alignment, and postoperative rotational stability. [10]
  • Even accurate preoperative planning may fail clinically if the IOL rotates or the posterior cornea is ignored.[11]

Table 8. Toric IOL Trials

Parameter Details
Year 2000s onward
Objective To evaluate toric IOLs for correction of pre-existing corneal astigmatism during cataract surgery.
Population Cataract patients with regular corneal astigmatism.
Design Randomized, prospective, or comparative clinical studies.
Main outcome Residual refractive cylinder, uncorrected distance visual acuity, rotational stability, and spectacle dependence.
Key results / impact Toric IOLs generally provide predictable astigmatism correction and better uncorrected distance vision in appropriately selected patients.
Limitations Accuracy depends on biometry, posterior corneal astigmatism, surgically induced astigmatism, IOL alignment, and postoperative rotation.

Table 9. Femtosecond Arcuate Keratotomy versus Toric IOL Trials

Parameter Details
Year 2020s; important contemporary randomized trials reported around 2025
Objective To compare femtosecond arcuate keratotomy with toric IOL implantation for astigmatism correction during cataract surgery.
Population Cataract patients with regular corneal astigmatism.
Design Randomized or prospective comparative trial.
Main outcome Residual astigmatism, refractive predictability, and uncorrected distance visual acuity.
Key results / impact Toric IOLs are generally more predictable for clinically significant regular astigmatism; femtosecond arcuate keratotomy may be useful for lower astigmatism or selected cases.
Limitations Arcuate keratotomy is nomogram-dependent; long-term stability and cost-effectiveness vary.

Presbyopia-Correcting and Premium IOL Trials

  • Premium IOL trials should be interpreted using functional and patient-reported outcomes rather than Snellen acuity alone.
  • Multifocal, trifocal, EDOF, and enhanced monofocal lenses differ in defocus range, contrast sensitivity, dysphotopsia, near vision, and patient satisfaction. [12][13][14][15][16][17]
  • Careful patient selection and counselling are important. (Table 10,11,12 and 13)

Table 10. Multifocal IOL Trials

Parameter Details
Year 1990s–2000s onward
Objective To compare multifocal IOLs with monofocal IOLs for spectacle independence after cataract surgery.
Population Cataract patients desiring reduced spectacle dependence.
Design Randomized or prospective comparative studies.
Main outcome Distance, intermediate, and near visual acuity; spectacle independence; contrast sensitivity; glare and halos.
Key results / impact Multifocal IOLs improve near vision and spectacle independence but may increase dysphotopsia and reduce contrast sensitivity compared with monofocal IOLs.
Limitations Patient selection is critical; outcomes are affected by ocular surface disease, macular pathology, personality, expectations, and neuroadaptation.

Table 11. Trifocal / Full Visual Range IOL Trials

Parameter Details
Year 2010s–2025
Objective To evaluate whether trifocal or full visual range IOLs provide better continuous vision than monofocal IOLs.
Population Cataract patients seeking reduced spectacle dependence across distance, intermediate, and near ranges.
Design Randomized controlled or prospective comparative trials.
Main outcome UDVA, UIVA, UNVA, defocus curve, dysphotopsia, contrast sensitivity, and satisfaction.
Key results / impact These lenses improve intermediate and near function compared with monofocal IOLs, but may increase glare, halos, and contrast-related symptoms.
Limitations Many studies are lens-specific and industry-sponsored; follow-up may be short; subjective outcomes vary.

Table 12. Extended-Depth-of-Focus IOL Trials

Parameter Details
Year 2010s onward
Objective To evaluate EDOF IOLs for improved range of vision with fewer photic phenomena than multifocal IOLs.
Population Cataract patients desiring improved intermediate vision and partial spectacle independence.
Design Randomized or prospective comparative studies.
Main outcome Intermediate vision, defocus curve, spectacle independence, contrast sensitivity, glare, and halos.
Key results / impact EDOF IOLs generally improve intermediate vision and may produce fewer dysphotopsias than multifocal IOLs, although near vision may be less strong than trifocal/multifocal designs.
Limitations Different EDOF designs are not interchangeable; results depend on lens design, pupil size, residual refractive error, and patient expectations.

Table 13. Enhanced Monofocal IOL Trials

Parameter Details
Year 2020s
Objective To assess whether enhanced monofocal IOLs improve intermediate vision while preserving monofocal-like visual quality.
Population Cataract patients receiving enhanced monofocal or standard monofocal IOLs.
Design Randomized or prospective comparative studies.
Main outcome Distance and intermediate visual acuity, contrast sensitivity, dysphotopsia, and spectacle use.
Key results / impact Enhanced monofocal IOLs may improve intermediate vision with relatively low dysphotopsia burden.
Limitations Near spectacle independence is limited compared with multifocal or trifocal IOLs; outcomes are lens-specific.

Adjustable IOL Trials

Light Adjustable Lens Trials

  • The Light Adjustable Lens(LAL) transforms the approach to refractive correction by enabling adjustments after the healing process, rather than depending solely on preoperative predictions. [18][19]
  • This is especially beneficial for eyes that are at risk of unexpected refractive outcomes. However, the advantages are heavily reliant on strict adherence to UV protection and lock-in protocols.
  • LAL offers postoperative refractive customization, but its success depends on patient compliance and access to specialzed treatment infrastructure.
  • Key parameters of this study are listed in Table 14 and 15.

Table 14. Light Adjustable Lens Trial

Parameter Details
Year 2017 FDA approval era; 2020s post-approval studies
Objective To evaluate safety and effectiveness of postoperative adjustable IOL power.
Population Cataract patients receiving a light adjustable lens.
Design Prospective pivotal and post-approval clinical studies.
Main outcome Residual refractive error, percentage within target refraction, UDVA, and safety.
Key results / impact The light adjustable lens allows postoperative adjustment of sphere and cylinder after healing, improving refractive precision.
Limitations Requires postoperative light treatments, UV protection compliance, specialized equipment, and multiple visits.
Potential advantage Trial endpoint
Postoperative refractive customization Percentage within +/-0.50 D of target
Residual astigmatism correction Postoperative cylinder
Adjustable monovision Binocular function and patient satisfaction
Reduced enhancement need Rate of laser enhancement
Compliance burden Completion of lock-in treatment protocol
Safety Inflammation, IOP, and phototoxicity-related concerns

Table 15. Light Adjustable Lens in Post-Refractive Surgery Eyes

Parameter Details
Year 2020s
Objective To evaluate LAL performance in eyes with previous LASIK, PRK, or RK, where IOL calculation is more difficult.
Population Cataract patients with prior corneal refractive surgery.
Design Retrospective or prospective clinical outcome studies.
Main outcome Refractive accuracy, residual spherical equivalent, residual astigmatism, and UDVA.
Key results / impact LAL may reduce refractive surprise in post-refractive surgery eyes by allowing postoperative adjustment.
Limitations Often nonrandomized; sample sizes may be small; selection bias and limited long-term comparative data.

IOL Formula and Biometry Studies

  • Modern IOL formula studies increasingly focus on difficult eyes rather than average eyes.
  • AI-based formulas, ray-tracing methods, and newer theoretical formulas are promising, but formula performance depends on biometry quality, constant optimization, device type, and subgroup-specific validation.[20][21](Table 16)
  • No single formula is universally best; the best choice depends on eye anatomy, prior surgery, data quality, and the validated population.


Table 16. IOL formula and biometry studies

Parameter Details
Year 1990s onward; AI/modern formula studies mainly 2010s–2020s
Objective To compare traditional vergence formulas, modern formulas, ray tracing, and AI/ML-based IOL formulas.
Population Routine cataract patients and complex eyes such as short eyes, long eyes, post-refractive surgery eyes, and keratoconus.
Design Retrospective or prospective comparative studies.
Main outcome Mean/median absolute error and percentage of eyes within ±0.25 D, ±0.50 D, and ±1.00 D of target refraction.
Key results / impact Newer formulas and AI-based approaches often improve refractive predictability, especially in complex eyes.
Limitations Many studies are not randomized; optimized lens constants, population differences, and biometry devices influence results.

Posterior Capsule Opacification Trials

PCO/IOL Material and Edge-Design Trials

  • PCO trials evaluate long-term surgical quality rather than immediate postoperative success.
  • IOL material, posterior optic edge geometry, capsulorhexis overlap, capsular stability, and lens epithelial cell migration all influence clinically meaningful PCO and Nd: YAG capsulotomy risk.[22][23]

Table 17. PCO, IOL material, and edge-design trials

Parameter Details
Year 1990s onward; long-term comparative reports continue into 2020s
Objective To evaluate the effect of IOL material, optic edge design, and surgical factors on posterior capsule opacification.
Population Cataract patients receiving different IOL models.
Design Randomized multicenter trials and long-term comparative studies.
Main outcome PCO score, visual acuity decline, contrast sensitivity, and Nd:YAG capsulotomy rate.
Key results / impact Sharp posterior optic edge and hydrophobic acrylic IOL designs generally reduce PCO and Nd:YAG capsulotomy rates.
Limitations Requires long follow-up; Nd:YAG rates depend on surgeon threshold, healthcare access, and local practice patterns.

Intraoperative and Postoperative Medication and Infection Prevention Trials

Intraoperative Antibiotic Trials

  • Real-world prophylaxis must consider regional drug availability, compound safety, antimicrobial resistance, and institutional policy.

Table 18. Intracameral antibiotic prophylaxis evidence

Parameter Details
Year 2006- 2007 onward
Objective To assess whether intracameral antibiotics reduce postoperative endophthalmitis after cataract surgery.
Population Cataract surgery patients.
Design Randomized trials and large registry/observational studies.
Main outcome Postoperative endophthalmitis rate.
Key results / impact Intracameral antibiotics, especially cefuroxime in ESCRS data, reduce postoperative endophthalmitis and have influenced prophylaxis guidelines.
Limitations Endophthalmitis is rare; drug choice, compounding safety, allergy, dose errors, and resistance patterns vary by region.

NSAID/Steroid Postoperative Regimen Trials

  • Postoperative anti-inflammatory trials should distinguish routine inflammation control from pseudophakic macular oedema prevention. [24][25][26]
  • The latter is risk-dependent and should be interpreted separately in diabetic, uveitic, retinal vascular, and prior macular oedema eyes.

Table 19.NSAID and steroid postoperative regimen trials

Parameter Details
Year 2000s onward
Objective To compare postoperative anti-inflammatory regimens after cataract surgery.
Population Cataract patients with or without risk factors for cystoid macular edema.
Design Randomized comparative trials.
Main outcome Anterior chamber inflammation, pain, cystoid macular edema, visual recovery, and IOP rise.
Key results / impact Steroids remain important for inflammation control; NSAIDs may reduce CME risk in selected patients, especially high-risk eyes.
Limitations Regimens and CME definitions vary; results differ between low-risk and high-risk patients.

Dropless Cataract Surgery Trials

  • Dropless cataract surgery is for adherence, particularly in elderly patients or those unable to administer drops reliably. [27]
  • However, depot anti-inflammatory therapy is less readily reversible than topical therapy, so IOP and inflammatory safety monitoring remain essential.

Table 20. Dropless cataract surgery trials

Parameter Details
Year 2010s–2020s
Objective To compare depot, intracameral, or transzonular medication approaches with conventional topical postoperative drops.
Population Cataract surgery patients.
Design Randomized or prospective comparative studies.
Main outcome Inflammation, CME, infection, adherence, patient satisfaction, IOP rise, and adverse effects.
Key results / impact Dropless approaches may improve adherence and convenience, especially in patients who struggle with topical drops.
Limitations Outcomes are formulation-specific; safety concerns include IOP rise, inflammation, medication toxicity, and limited reversibility of depot therapy.

Surgical AI and Digital Cataract Studies

  • Surgical AI is an emerging educational and quality-improvement domain.
  • Current systems can analyze surgical video for phase recognition, instrument tracking, skill assessment, complication prediction, and structured feedback.[28] (Table 21 and 22)
  • Most evidence remains retrospective or dataset-based; prospective studies are needed to prove improvement in patient outcomes. [29]

Table 21.Cataract Surgical Video AI Studies

Parameter Details
Year 2010s–2020s
Objective To develop and validate AI systems for surgical phase recognition, instrument tracking, skill assessment, and complication detection.
Population Cataract surgery video datasets such as Cataract-101, Cataract-1K, and related datasets.
Design Dataset-based AI validation studies.
Main outcome Phase recognition accuracy, segmentation performance, irregularity detection, and instrument tracking accuracy.
Key results / impact Surgical video AI may support training, quality improvement, operative workflow analysis, and future real-time surgical assistance.
Limitations Mostly retrospective and video-based; patient outcome benefit has not yet been proven; many systems remain research tools.

Table 22.AI/LLM Cataract Surgery Planning Studies

Parameter Details
Year 2020s
Objective To evaluate whether AI or large language models can assist with cataract surgery planning, IOL selection, or structured decision support.
Population Cataract surgery planning datasets or simulated/structured clinical cases.
Design Benchmark or model-development studies.
Main outcome Planning accuracy, reasoning performance, IOL recommendation quality, and safety of generated output.
Key results / impact AI may support structured cataract planning and documentation in the future.
Limitations Preclinical/benchmark-level evidence; not ready for autonomous surgical decision-making; hallucination and unsafe recommendations remain concerns.

Special Population Studies

Cataract Surgery in Diabetes and Diabetic Macular Edema

  • Diabetic eyes require a retinal lens to cataract trial interpretation: visual gain may be limited by macular status, and surgery can exacerbate macular edema through inflammation and blood-retinal barrier disruption. [30]
  • Preoperative DME optimization and postoperative OCT monitoring are central.

Table 23.Cataract surgery in diabetes and diabetic macular edema

Parameter Details
Year 2000s-2020s
Objective To evaluate visual outcomes, macular edema risk, and perioperative treatment strategies in eyes with diabetes, diabetic retinopathy, or diabetic macular edema.
Population Cataract patients with diabetes, diabetic retinopathy, or pre-existing DME.
Design Randomized trials, comparative studies, and systematic reviews of anti-inflammatory or anti-VEGF strategies.
Main outcome Visual acuity, central macular thickness, DME progression, and need for retinal treatment.
Key results / impact Cataract surgery improves vision in many diabetic eyes, but pre-existing DME/DR increases risk of postoperative macular edema; retinal optimization and OCT monitoring are important [24,27].
Limitations Heterogeneous DR severity, DME status, anti-VEGF use, OCT endpoints, and perioperative protocols.

Cataract Surgery in Uveitis

  • Cataract surgery in patients with uveitis has been shown to yield visual acuity levels within the normal range in the majority of cases.
  • The review indicates that effective preoperative control of uveitis, the use of either acrylic or HSM intraocular lenses (IOLs), and a diagnosis of Fuchs heterochromic cyclitis are correlated with improved surgical outcomes. (Table 24)
  • Uveitides that involve the posterior segment tend to result in poorer outcomes, likely due to complications associated with vision impairment related to uveitis.[31][32]

Table 24. Clinical Trials on cataract surgery in Uveitis

Parameter Details
Year Mostly observational and comparative evidence
Objective To evaluate cataract surgery outcomes and perioperative inflammation control in uveitic eyes.
Population Patients with uveitis-associated cataract.
Design Cohort studies, comparative studies, and perioperative treatment studies.
Main outcome Visual acuity, postoperative inflammation, CME, uveitis recurrence, and IOL tolerance.
Key results / impact Good outcomes are possible when inflammation is controlled preoperatively and perioperative anti-inflammatory therapy is optimized [28].
Limitations Heterogeneous uveitis etiologies, immunosuppressive regimens, activity definitions, and surgical risk profiles.

Cataract Surgery in Age- Related Macular Degeneration

Studies have shown that cataract surgery may be linked with increased risk of development and progression of age-related macular degeneration.[33](Table 25)

Table 25. Trials in Cataract Surgery in Age- Related Macular Degeneration

Parameter Details
Year 2000s-2020s
Objective To evaluate visual outcomes and AMD progression risk after cataract surgery.
Population Cataract patients with dry or neovascular AMD.
Design Cohort studies, registry studies, and systematic reviews.
Main outcome Visual acuity, quality of life, AMD progression, and need for anti-VEGF therapy.
Key results / impact Cataract surgery can improve vision and quality of life in selected AMD patients, but counseling should be individualized according to macular status and visual potential [29].
Limitations Confounding by AMD severity, anti-VEGF treatment status, and variable follow-up.

Timing, Service Delivery, and Patient Centered Outcomes

  • Modern cataract evidence increasingly evaluates service delivery and patient-centered outcomes, including immediate sequential bilateral cataract surgery, functional improvement, quality of life, driving, independence, and falls.
  • Studies suggest that immediate sequential bilateral cataract surgery is safe and effective alternative to delayed sequential bilateral cataract surgery .[34][35][36]


Table 26. Immediate Sequential Bilateral Cataract Surgery

Parameter Details
Year 2020s; contemporary reviews and service-delivery studies
Objective To compare immediate sequential bilateral cataract surgery with delayed sequential bilateral cataract surgery.
Population Adults undergoing bilateral cataract surgery.
Design Comparative studies, systematic reviews, and service-delivery analyses.
Main outcome Visual outcomes, safety, patient acceptance, complications, cost, and healthcare efficiency.
Key results / impact Selected patients may benefit from fewer visits, faster binocular rehabilitation, and improved efficiency; strict bilateral asepsis protocols are essential [30].
Limitations Concerns include bilateral complications, refractive surprise, consent, medicolegal issues, and need for separate instruments/drug batches for each eye.

Table 27. Quality of Life and Functional Outcomes

Parameter Details
Year 1990s onward
Objective To assess cataract surgery effects on quality of life, visual function, falls, driving, mobility, and independence.
Population Adults with visually significant cataract.
Design Randomized timing studies, cohort studies, registry studies, and patient-reported outcome studies.
Main outcome Quality of life, visual function, falls, fractures, driving safety, and independence.
Key results / impact Cataract surgery improves visual function and patient-reported quality of life; second-eye surgery may further improve binocular function.
Limitations Patient-reported outcomes vary by questionnaire, baseline function, ocular/systemic comorbidity, adaptation, and social context.

Limitations of Cataract Clinical Trials

  • Cataract clinical trials are limi d by heterogeneity in surgical technique, surgeon experience, IOL model, biometry method, ocular comorbidities, follow-up duration, and patient expectations.
  • Visual acuity alone may not fully capture patient experience, particularly in premium IOL studies where contrast sensitivity, glare, halos, spectacle independence, and satisfaction are critical.
  • Rare complications such as endophthalmitis, retinal detachment, posterior capsule rupture, IOL explantation, and severe dysphotopsia require very large studies or registry-level data.
  • For emerging technologies such as surgical AI, LLM-based cataract planning, robotic assistance, and new adjustable or premium IOLs, early performance metrics should not be interpreted as proof of patient outcome benefit.
  • Prospective validation, external reproducibility, patient-centred outcomes, and cost-effectiveness data are essential before routine adoption.

References

  1. ↑ Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96. PMID: 7487614.
  2. ↑ Doft BH. The endophthalmitis vitrectomy study. Arch Ophthalmol. 1991 Apr;109(4):487-9. doi: 10.1001/archopht.1991.01080040055025. PMID: 2012545.
  3. ↑ Endophthalmitis Study Group, European Society of Cataract & Refractive Surgeons. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg. 2007 Jun;33(6):978-88. doi: 10.1016/j.jcrs.2007.02.032. PMID: 17531690.
  4. ↑ Infant Aphakia Treatment Study Group; Lambert SR, Lynn MJ, Hartmann EE, DuBois L, Drews-Botsch C, Freedman SF, Plager DA, Buckley EG, Wilson ME. Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years. JAMA Ophthalmol. 2014 Jun;132(6):676-82. doi: 10.1001/jamaophthalmol.2014.531. PMID: 24604348; PMCID: PMC4138810.
  5. ↑ Infant Aphakia Treatment Study Group. A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy. Archives of Ophthalmology. 2010.https://doi.org/10.1016/j.ajo.2014.07.031
  6. ↑ Freedman SF, Beck AD, Nizam A, et al. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021;139(2):165–173. doi:10.1001/jamaophthalmol.2020.5664
  7. ↑ Schweitzer C, Brezin A, Cochener B, Monnet D, Germain C, Roseng S, Sitta R, Maillard A, Hayes N, Denis P, Pisella PJ, Benard A; FEMCAT study group. Femtosecond laser-assisted versus phacoemulsification cataract surgery (FEMCAT): a multicentre participant-masked randomised superiority and cost-effectiveness trial. Lancet. 2020 Jan 18;395(10219):212-224. doi: 10.1016/S0140-6736(19)32481-X. PMID: 31954466.
  8. ↑ Day AC, Burr JM, Bennett K, Bunce C, Doré CJ, Rubin GS, Nanavaty MA, Balaggan KS, Wilkins MR; FACT group. Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial. Ophthalmology. 2020 Aug;127(8):1012-1019. doi: 10.1016/j.ophtha.2020.02.028. Epub 2020 Mar 3. PMID: 32386810; PMCID: PMC7397499.
  9. ↑ Lee, SH., Chiu, YC., Tsai, PC. et al. Femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery: a meta-analysis of randomized controlled trials. Sci Rep 15, 27569 (2025). https://doi.org/10.1038/s41598-025-13174-1
  10. ↑ Kessel L, Andresen J, Tendal B, Erngaard D, Flesner P, Hjortdal J. Toric Intraocular Lenses in the Correction of Astigmatism During Cataract Surgery: A Systematic Review and Meta-analysis. Ophthalmology. 2016 Feb;123(2):275-286. doi: 10.1016/j.ophtha.2015.10.002. Epub 2015 Nov 18. PMID: 26601819.
  11. ↑ Verstraaten JH, Buzzi M, Masalkhi M, Behndig A, Cochener B, Day AC, Dick HB, Findl O, Lapid-Gortzak R, Kohnen T, Nuijts R, Rosen P, van den Biggelaar FJHM, Abulafia A, Virgili G, Dickman MM. Correcting Astigmatism Using Toric Intraocular Lenses During Cataract Surgery. Am J Ophthalmol. 2026 Jun;286:248-262. doi: 10.1016/j.ajo.2026.02.043. Epub 2026 Feb 28. PMID: 41771334.
  12. ↑ de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4. PMID: 27943250; PMCID: PMC6463930.
  13. ↑ Cao K, Friedman DS, Jin S, et al. Multifocal versus monofocal intraocular lenses for age-related cataract patients: a systematic review and meta-analysis. Survey of Ophthalmology. 2019.https://doi.org/10.1016/j.survophthal.2019.02.012
  14. ↑ Wanten JC, Bauer NJC, Berendschot TTJM, van den Biggelaar FJHM, Nuijts RMMA. Two novel extended depth-of-focus intraocular lenses targeted for mini-monovision: A prospective randomized controlled trial. Am J Ophthalmol. 2025 Aug;276:286-296. doi: 10.1016/j.ajo.2025.04.024. Epub 2025 Apr 24. PMID: 40287004.
  15. ↑ Wanten JC, Bauer NJC, Berendschot TTJM, van den Biggelaar FJHM, Nuijts RMMA. Two novel extended depth-of-focus intraocular lenses targeted for mini-monovision: A prospective randomized controlled trial. Am J Ophthalmol. 2025 Aug;276:286-296. doi: 10.1016/j.ajo.2025.04.024. Epub 2025 Apr 24. PMID: 40287004.
  16. ↑ Muzychuk A, Harasymowycz P. Efficacy and safety evaluation of a new full visual range vs monofocal intraocular lens in patients with cataract: randomized, controlled Canadian clinical trial. J Cataract Refract Surg. 2025 Oct 1;51(10):867-875. doi: 10.1097/j.jcrs.0000000000001714. PMID: 40490939; PMCID: PMC12447810.
  17. ↑ Trusiak ZH, Leoniuk A, Tomaszuk A, Sawicki M, Konopińska J. Enhanced Monovision Intraocular Lenses: Current Status and Future Perspectives-Systematic Review. Biomedicines. 2025 Dec 29;14(1):74. doi: 10.3390/biomedicines14010074. PMID: 41595610; PMCID: PMC12838369.
  18. ↑ Folden DV, Wong JR. Visual Outcomes of an Enhanced UV Protected Light Adjustable Lens Using a Novel Co-Managed, Open-Access Methodology. Clin Ophthalmol. 2022 Aug 4;16:2413-2420. doi: 10.2147/OPTH.S378525. PMID: 35957659; PMCID: PMC9359783.
  19. ↑ Nakagama M, Nagesh D, Doane J. Comparative Analysis of Postoperative Visual Outcomes of Light-Adjustable Lens, Toric Monofocal, and Spherical Monofocal Intraocular Lenses. Mo Med. 2025 Sep-Oct;122(5):417-423. PMID: 41132458; PMCID: PMC12543345.
  20. ↑ Wang L, Burwinkel H, Bensaid N, Koch DD. Evaluation of an artificial intelligence-based intraocular lens calculator: AI-based IOL-optimized formula. J Cataract Refract Surg. 2024 Dec 17;51(4):332–6. doi: 10.1097/j.jcrs.0000000000001603. Epub ahead of print. PMID: 39682055; PMCID: PMC11980897.
  21. ↑ Stopyra W, et al. Prediction of artificial intelligence-based intraocular lens formulas. American Journal of Ophthalmology. 2026https://doi.org/10.1016/j.ajo.2026.02.017
  22. ↑ Auffarth, G.U., Brézin, A., Lignereux, F. et al. Randomized multicenter trial to assess posterior capsule opacification and glistenings in two hydrophobic acrylic intraocular lenses. Sci Rep 13, 2822 (2023). https://doi.org/10.1038/s41598-023-29855-8
  23. ↑ Leydolt C, Schartmüller D, Schwarzenbacher L, Röggla V, Schriefl S, Menapace R. Posterior Capsule Opacification With Two Hydrophobic Acrylic Intraocular Lenses: 3-Year Results of a Randomized Trial. Am J Ophthalmol. 2020 Sep;217:224-231. doi: 10.1016/j.ajo.2020.04.011. Epub 2020 Apr 23. PMID: 32335056.
  24. ↑ Lang M, Xuan J, Li X, Liu MM, Xu J, Liu T. Comparative efficacy of non-steroidal anti-inflammatory drugs in preventing postoperative macular edema following cataract surgery: a systematic review and Network Meta-analysis. Int J Ophthalmol. 2025 Sep 18;18(9):1730-1736. doi: 10.18240/ijo.2025.09.15. PMID: 40881431; PMCID: PMC12378685.
  25. ↑ Almasri, M., Ismaiel, A., Gavris, I. et al. Topical NSAIDs impact on macular oedema and visual outcome after phacoemulsification: systematic review of RCTs with network meta-analysis. Eye 38, 3222–3230 (2024). https://doi.org/10.1038/s41433-024-03268-x
  26. ↑ Hoffman RS, Braga-Mele R, Donaldson K, Emerick G, Henderson B, Kahook M, Mamalis N, Miller KM, Realini T, Shorstein NH, Stiverson RK, Wirostko B; ASCRS Cataract Clinical Committee and the American Glaucoma Society. Cataract surgery and nonsteroidal antiinflammatory drugs. J Cataract Refract Surg. 2016 Sep;42(9):1368-1379. doi: 10.1016/j.jcrs.2016.06.006. PMID: 27697257; PMCID: PMC5531861.
  27. ↑ Huang, A.Y., Rao, N., Sulewski, M.E. et al. Dropless cataract surgery: comparing sub-Tenon’s and topical steroids for postoperative inflammation prophylaxis. Eye 40, 848–853 (2026). https://doi.org/10.1038/s41433-026-04309-3
  28. ↑ Giap BD, et al. CatSkill: artificial intelligence-based metrics for the assessment of surgical skill level from intraoperative cataract surgery video recordings. Ophthalmology Science. 2025https://doi.org/10.1016/j.xops.2025.100764
  29. ↑ Cataract-LMM: large-scale, multi-source, multi-task benchmark for deep learning in surgical video analysis. 2025 preprinthttps://doi.org/10.48550/arXiv.2510.16371
  30. ↑ Lee SH, Tseng BY, Wu MC, Wang JH, Chiu CJ. Incidence and Progression of Diabetic Retinopathy After Cataract Surgery: A Systematic Review and Meta-Analysis. Am J Ophthalmol. 2025 Jan;269:105-115. doi: 10.1016/j.ajo.2024.08.017. Epub 2024 Aug 22. PMID: 39179126.
  31. ↑ Mehta S, Linton MM, Kempen JH. Outcomes of cataract surgery in patients with uveitis: a systematic review and meta-analysis. Am J Ophthalmol. 2014 Oct;158(4):676-692.e7. doi: 10.1016/j.ajo.2014.06.018. Epub 2014 Jun 28. PMID: 24983790.
  32. ↑ Al-Essa RS, Alfawaz AM. New insights into cataract surgery in patients with uveitis: A detailed review of the current literature. Saudi J Ophthalmol. 2022 Feb 18;36(2):133-141. doi: 10.4103/sjopt.sjopt_147_21. PMID: 36211311; PMCID: PMC9535913.
  33. ↑ Yang L, Li H, Zhao X, Pan Y. Association between Cataract Surgery and Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis. J Ophthalmol. 2022 May 5;2022:6780901. doi: 10.1155/2022/6780901. PMID: 35573811; PMCID: PMC9098349.
  34. ↑ Kessel L, Andresen J, Erngaard D, Flesner P, Tendal B, Hjortdal J. Immediate Sequential Bilateral Cataract Surgery: A Systematic Review and Meta-Analysis. J Ophthalmol. 2015;2015:912481. doi: 10.1155/2015/912481. Epub 2015 Aug 17. PMID: 26351576; PMCID: PMC4553313.
  35. ↑ Aiello F, et al. Immediate sequential versus delayed sequential bilateral cataract surgery: systematic review and meta-analysis. Journal of Cataract & Refractive Surgery. 2023.https://doi.org/10.1097/j.jcrs.0000000000001230
  36. ↑ Al-Swailem, S., Ahmad, K., AlJbreen, A. J., & AlHilali, S. (2026). Immediate Versus Delayed Sequential Bilateral Cataract Surgery: A Systematic Review. Clinical Ophthalmology, 20. https://doi.org/10.2147/OPTH.S581259
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