Robotic-Assisted Vitreoretinal Surgery
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Surgical Therapy
Robotic-assisted vitreoretinal surgery (RAVS) offers a transformative approach to managing complex retinal conditions by enhancing surgical precision, reducing physiological tremor, and enabling micrometer-scale maneuvers beyond the capabilities of the human hand.[1] [2] Systems such as the Preceyes Robotic Surgical System—which has received CE marking—have demonstrated success in performing delicate tasks like internal limiting membrane (ILM) peeling, subretinal injections, and retinal vein cannulation, which are critical for the delivery of gene therapy and stem cell-based treatments [3][4] [5]
These systems utilize motion scaling, tremor filtering, and virtual z-boundaries to minimize iatrogenic trauma and enhance instrument control in the subretinal space [6][4]. Recent randomized controlled simulator studies have shown that robotic assistance significantly improves surgical precision and reduces retinal tissue damage, especially in novice surgeons, though at the cost of increased operative time.[4] Despite these advancements, current limitations include high cost, limited accessibility, and the need for specialized training [7][8] Future directions focus on integrating real-time force feedback, artificial intelligence, and intraoperative optical coherence tomography (OCT) to further refine robot-assisted performance and expand its adoption in clinical practice. [9][10]
Background/Historical Overview
The evolution of RAVS spans over five decades and reflects broader technological advancements in precision medicine. Initial progress in ophthalmic robotics began with Robert Machemer’s introduction of the handheld motorized vitrectomy cutter in the 1970s, a tool that revolutionized the management of posterior segment diseases by enabling safe and controlled removal of the vitreous. [11] This was followed in the 1980s by the development of early ocular micromanipulators by Spitznas and later Guerrouad and Vidal, setting the stage for more complex microsurgical instrumentation. [12][13]
The broader field of robotic surgery underwent significant transformation during the 1980s and 1990s, with platforms like PUMA 200 and RoboDoc used for neurosurgery and orthopedics, respectively. [14] [15] However, it wasn't until 2007 that robotic systems entered ophthalmology, when the da Vinci Surgical System was used to repair corneal lacerations in porcine eyes using 10-0 nylon sutures.[16] Despite its precision, the da Vinci system’s 1-mm resolution proved inadequate for retinal surgery, which often requires micron-scale precision. [17]
This precision gap drove the development of specialized robotic systems for vitreoretinal surgery, where the high sensitivity of retinal tissue demands ultra-fine control [18][5]. Since then, over 12 robotic platforms have been developed, the majority still in preclinical stages. Notably, only two systems have reached clinical use: the Preceyes Surgical System and the KU Leuven co-manipulator. [19] Preceyes, developed in the Netherlands, became the first system to receive CE marking in 2019 and remains the most widely studied.[19][20]
Modern Pre-clinical vitreoretinal robotic systems fall into three main categories:
- Handheld tools like the Micron, developed through collaboration between Carnegie Mellon and Johns Hopkins, are designed to cancel physiological tremor. Micron has demonstrated a 90% reduction in tremor and significantly improved success rates for retinal vein cannulation in porcine models. [21][22]
- Co-manipulation platforms such as the Steady-Hand Eye Robot, also from Johns Hopkins, utilize force-sensing technology to smooth manual tool movements and reduce tremor without removing surgeon control. [23][24]
- Telemanipulator systems like the Preceyes Surgical System and IRISS (developed at UCLA) use master-slave configurations, motion scaling, and advanced imaging. IRISS is designed for both anterior and posterior segment surgeries and allows surgeons to operate from a remote console with 3D visualization and real-time joystick input. [25][8][26]
Other innovative platforms include the RAMSIS system from the Technical University of Munich, which employs hybrid actuation with piezoelectric motors and has shown success in subretinal depth tracking in pig eyes using OCT guidance. [27][28][29] Additionally, OctoMag, a magnetically controlled system, enables intraocular manipulation of microrobots without tethers. Though promising for subretinal injections and vein cannulation, OctoMag systems currently face challenges with alignment precision and angular control. [30][31]
In clinical application there are two systems that are currently in use, the KU Leuven co-manipulator system stabilizes the eye and enhances precision using motion-opposing force feedback. In its first human trial, surgeons used it to inject ocriplasmin into retinal veins for up to 10 minutes in four patients, demonstrating the feasibility of robotic retinal vein cannulation. [32][33]
The other system that is currently in clinical use is the Preceyes Surgical System remains at the forefront of clinical translation. Offering 10 µm tool-tip resolution, it supports standard vitrectomy instruments and integrates intraoperative OCT and virtual safety boundaries to ensure precision and safety. [20][34] In randomized controlled trials, Preceyes has shown comparable efficacy and safety to manual techniques for ILM peeling and subretinal delivery of tissue plasminogen activator (TPA), suggesting its potential in gene and cell therapy applications. [3][35]
Integration into Practice:
For ophthalmologists to successfully integrate RAVS into their surgical practice, three key considerations should be addressed:
Cost: Robotic systems like the PRECEYES Surgical System, da Vinci (adapted), or other microsurgical platforms require substantial capital investment, often ranging from hundreds of thousands to over a million USD, depending on the system and necessary modifications for ophthalmic use.[36] Ongoing maintenance contracts, software upgrades, and technician support can add significantly to the long-term cost. In addition, training surgical teams — both surgeons and scrub staff — involves additional time and financial resources. Currently, no dedicated reimbursement codes exist for RAVS procedures, which can make cost recovery more difficult for private practices and smaller centers. Hospitals may hesitate to invest without a clear financial return. Though upfront costs are high, potential long-term benefits — such as increased precision, fewer complications, shorter recovery times, and possibly reduced OR time — may offset the investment. However, this cost-benefit relationship is not yet well-documented in large-scale, peer-reviewed economic evaluations.
Operating Room Set-up Time: In other surgical disciplines, robotic procedures are well-documented to require longer setup times. One study reported that robotic surgery setup took, on average, over 20 minutes longer than manual surgical preparation. [37]While RAVS systems initially require longer operative times due to setup and the learning curve, recent advancements, and increased surgeon experience have demonstrated that procedure durations can become comparable to those of manual surgery. [35]
Flattening the learning curve: There will be a substantial learning curve for the surgeon but also for the surgical assistant and team in the operating room. Standardized training modules for robotic ophthalmic trainees and surgical teams will allow for improved safety outcomes for patients elective for RAVS. [38]
Patient Selection
Indications
Robotic-assisted vitreoretinal surgery is primarily recommended for procedures that demand a level of precision and stability beyond the physiological limits of manual dexterity. This technology has shown feasibility and safety for several vitreoretinal interventions where micron-level accuracy is essential.[39]
Epiretinal Membrane (ERM) and Internal Limiting Membrane (ILM) Peeling: The removal of these extremely thin membranes from the retinal surface requires meticulous technique to avoid damaging the delicate underlying neural tissue. Robotic systems provide enhanced precision and control in these procedures.[39] In clinical trials using the Preceyes Surgical System, ERM peels were completed with high accuracy. [40] These cases were chosen as early evaluations of robotic systems because they are commonly performed yet technically challenging, serving as robust indicators for gauging robotic precision. [19]
Subretinal Injections: Precisely delivering therapeutic agents into the subretinal space is increasingly vital for emerging gene and cell therapies. Robotic platforms show promise in improving accuracy and control during these delicate injections. [39] As approved treatments like voretigene neparvovec-rzyl (Luxturna) gain traction for inherited retinal diseases, precise and minimally traumatic administration is critical to achieving optimal outcomes. [19] Robotic-assisted systems help maintain consistent cannula positioning and infusion rates, thereby minimizing reflux and accidental tissue damage. [39]
Retinal Vein Cannulation (RVC): Addressing retinal vein occlusions via cannulation of the occluded vessel and direct delivery of thrombolytic drugs is extremely challenging due to the small diameter and fragility of retinal vessels. By stabilizing instruments and filtering out hand tremors, robotics can make these procedures more feasible. [41] The KU Leuven co-manipulator system accomplished the first robot-assisted RVC in humans, enabling stable injection of ocriplasmin for up to 10 minutes. [40]This procedure, which necessitates sustained needle placement in vessels measuring only 80-120 μm at the optic disc, exemplifies the potential of robotic systems for treatments previously considered unachievable.[19]
Submacular Hemorrhage Management: Research shows the successful application of robotic surgery for subretinal drug delivery in the management of submacular hemorrhage. [19] In such cases, the Preceyes system was used to administer recombinant tissue plasminogen activator (r-TPA) subretinally under local anesthesia in patients with hemorrhage secondary to age-related macular degeneration. Clinical trials noted fewer retinotomies and reduced retinal microtrauma when compared with manual techniques. [42]
Complex Micron-Scale Interventions: Certain advanced vitreoretinal procedures, including tractional retinal detachment repairs, require coordinated bimanual maneuvers at a microscopic level, pushing human dexterity to its limits. Robotic assistance may offer the stability and precision necessary for these intricate surgical tasks.[39] Comparative studies suggest reduced retinal microtrauma with robot-assisted methods, indicating potential safety benefits for delicate maneuvers near the macula. [19]
Contraindications
Even though RAVS continues to broaden its scope, certain factors must be considered to determine optimal patient selection. Contraindications often relate to the patient-specific factors, current limitations of robotic technology, or surgeon-related considerations.
Patient-Related Factors: Some RAVS may take more time to complete compared to standard manual surgery, which can be a drawback in urgent cases where delay might lead to irreversible vision loss. [39] Though several robotic procedures can be done under local anesthesia, certain systems or complex interventions might require general anesthesia with neuromuscular blockade to ensure patient stillness—an important consideration for those with higher anesthesia-related risks. [43]
Patients with pronounced involuntary eye movements or difficulty maintaining a steady gaze may also be unsuitable for robotic surgery, as these issues could undermine the precision of robotic instrument manipulation. [40] In addition, specific anatomical characteristics that limit robotic instrument access may serve as relative contraindications.
Limitations of Current Robotic Technology: One notable drawback of many robotic systems is the lack of tactile or force feedback, which is particularly important in delicate intraocular environments. [39] Surgeons often rely on subtle tactile cues to prevent tissue damage, especially as the forces involved can fall below the threshold of human tactile perception. [41] Furthermore, the bulk of some robotic devices and the limited availability of specialized ophthalmic instruments designed for robotic use can restrict certain applications. [44]
Additional technical hurdles include potential sensor-actuation lag, high computational demands for real-time intraoperative OCT, and alignment discrepancies between the robotic mechanism and the patient’s eye—all of which may influence safety and efficacy in specific scenarios. [45] Moreover, the cost and maintenance associated with these systems, along with limited accessibility at many centers, remain practical barriers that can limit widespread adoption. [40]
Surgeon-Related Factors: Safe and effective use of robotic platforms requires specialized training and experience. The learning curve can limit the immediate availability of surgeons proficient in this technology, consequently restricting patient access. [41] In instances where a surgeon already has extensive proficiency in manual vitreoretinal techniques with excellent outcomes, the perceived advantages of switching to robotics may not outweigh the time and effort needed to adapt. [40]
Surgical Technique
Preoperative Planning and Setup: A comprehensive preoperative assessment, including detailed fundus evaluation and OCT imaging, is essential to plan the surgical approach and define the target area. [46] After preparing the patient and administering appropriate anesthesia, the robotic system (e.g., Preceyes) is positioned—often at the temporal side of the operating table—and meticulously draped. [19]
The patient’s head is stabilized using a specialized headrest to maintain consistent eye orientation, critical for ensuring precision during robotic manipulation. [47]Access ports for robotic instruments and illumination are created using standard small-gauge vitreoretinal trocars (commonly 23–27 gauge). For the Preceyes system, a conical-shaped scleral port adaptor secures the manipulator to the eye, maintaining a steady platform for intraocular maneuvers. [19]
Robotic Systems and Control Mechanisms: Various robotic systems exist, each with unique design features. The Preceyes Surgical System (CE-marked) employs a telemanipulator strategy where the surgeon controls a motion controller, which drives a robotic arm to achieve tool-tip accuracy of around 10 μm. [19]
During surgery, the surgeon manipulates the robotic arm via intuitive hand controls. Many setups include motion scaling, converting larger hand movements into fine, precise movements at the instrument tip. [48] These systems can also dampen physiological tremors (typically 8–12 Hz), significantly improving stability during delicate tasks. [41]
Preceyes allows the surgeon to maneuver in four axes using a hand-motion controller, translating broad-scale surgeon inputs into precise movements within the eye. [19] Some platforms incorporate virtual boundaries to prevent instruments from exceeding predefined limits in the ocular space, and many offer a “hold” or “freeze” feature that stabilizes the instrument tip during particularly delicate phases. [48]
Surgical Procedures and Techniques: In membrane peeling (ERM or ILM), a conventional pars plana vitrectomy is first performed. The robotic component then controls a fine needle or pick to initiate a flap on the membrane away from the macular surface, guided by intraoperative OCT. [19] Although robotic procedures generally take longer, clinical outcomes have been equivalent or superior to manual surgery, with decreased rates of microtrauma or minor bleeding. [19]
For subretinal injections, the Preceyes system has facilitated subretinal administration of recombinant tissue plasminogen activator (r-TPA) under local anesthesia in patients presenting with submacular hemorrhage. Following vitrectomy, a 41G cannula is advanced toward the hemorrhagic area under z-axis control, connected to a foot-controlled fluid system for steady injection under real-time OCT visualization. [19] Fewer retinotomies and less retinal damage have been reported when compared to conventional techniques. [42]
In RVC, initial studies using the Preceyes system in animal models have shown successful vein entry and maintenance of the cannula for up to 20 minutes. [19] The KU Leuven co-manipulator system accomplished the first human RVC by stabilizing a needle tip in the vein to deliver ocriplasmin for 10-minute intervals. [40]
Integration with Imaging Technologies: The incorporation of intraoperative OCT in robotic surgery marks a significant advancement, providing high-resolution, real-time cross-sectional images of the surgical field. This allows for precise visualization of instrument-to-tissue interactions. [49] For the Preceyes system, real-time OCT helps confirm accurate retinotomy creation, facilitates subretinal injections, and monitors bleb formation. [19]
Outcomes
Robotic-assisted vitreoretinal surgery (RAVS) has shown promising outcomes in terms of precision and safety, although it generally requires more time compared to manual surgery. Here, are some of the measured outcomes that have been explored in RAVS.
Surgical Success: Current evidence is mixed regarding whether RAVS yields outcomes equivalent to or better than those of manual surgical techniques. A randomized controlled trial found that both experienced and novice vitreoretinal surgeons achieved greater precision and caused less tissue damage using robotic-assisted techniques compared to manual surgery.[50]
- Compensation for physiologic tremor: A physiological hand tremor with a mean amplitude of 156 micrometers is inherent to vitreoretinal surgeons. Robotic surgical technologies aim to identify and counteract this tremor in real time.[51][52]
- Prevention of Eye Rotation: One significant advantage of RAVS is the implementation of adaptive force control methods, which actively counteract any excessive forces applied to the sclera, thereby stabilizing the eye and preventing unintended movements.[53]
- Increased ability for tool immobilization: Systems like the Steady-Hand Eye Robot (SHER) employ optimized tilt mechanisms and adaptive force control strategies to maintain tool stability. They actively mitigate excessive forces applied to the sclera, ensuring precise tool placement and minimizing the risk of tissue damage.[54]
Longer Operative Time: The first human study of remotely controlled robot-assisted retinal surgery performed through a telemanipulation device was done on 12 patients. Each group—manual surgery and RAVS—included six patients. Overall, the surgical time including dissection was significantly longer in the RAVS group (4 mins 5 seconds median time) when compared to the manual surgery group (1 min 20 seconds). [3] Prolonged operative time, however, may elevate the risk of intraoperative and postoperative complications.
Learning Curve and Training Considerations: Successful implementation of RAVS hinges on targeted training programs. Familiarity with the Preceyes system, for example, is often gained through simulations and team-based sessions with surgeons, assistants, and operating room staff. [19] Comparative studies reveal that while the learning trajectories for robot-assisted and manual surgery may be similar, robot-assisted approaches can reduce overall instrument movement and tissue stress—benefits that are particularly relevant for less experienced surgeons.[50]
Complications
Common complications associated with vitreoretinal surgery include cataract formation, retinal breaks, retinal detachments, endophthalmitis, and macular hole formation. For example, endophthalmitis is rare, occurring in less than 0.05% of vitrectomies. Macular hole formation is also a potential complication, particularly in surgeries for epiretinal membrane and vitreomacular traction.[55] The complication rates of RAVS and manual surgery are comparable in both incidence and types of complications, with neither approach linked to a higher risk of adverse outcomes.[50]
Equipment Failure: As with all robotic systems, there exists a risk of equipment malfunction or failure, potentially causing intraoperative delays or requiring conversion to manual surgery.[56]
Reduced Sensory Feedback: Surgeons may have limited tactile feedback, which could impair their ability to assess the force applied during delicate maneuvers, thereby potentially raising the risk of iatrogenic injury.[53]
Conclusion
Robotic-assisted vitreoretinal surgery (RAVS) represents a groundbreaking advancement in ophthalmic microsurgery, offering enhanced precision, stability, and control beyond the limits of the human hand. While still in its early stages, RAVS has demonstrated promising outcomes in complex tasks such as subretinal injections and membrane peeling. However, widespread adoption will depend on addressing key challenges, including high initial costs, integration into surgical workflows, and the need for specialized training. As technology evolves and evidence accumulates, RAVS has the potential to redefine the future of vitreoretinal surgery.
References
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- ↑ Turgut F, Somfai GM, Heussen FM, Eberle A, de Smet MD, Becker MD. Robot-Assisted Epiretinal Membrane Peeling: A Prospective Assessment of Pre- and Intra-Operative Times and of Surgeons’ Subjective Perceptions. Journal of Clinical Medicine. 2023;12(8):2768. doi:10.3390/jcm12082768
- ↑ 48.0 48.1 Wang T, Xia J, Jin L, et al. Comparison of robot-assisted vitreoretinal surgery and manual surgery in different preclinical settings: a randomized trial. Annals of Translational Medicine. 2022;10(21):1163-1163. doi:10.21037/atm-22-1315
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- ↑ 50.0 50.1 50.2 Forslund Jacobsen M, Konge L, Alberti M, la Cour M, Park YS, Thomsen ASS. ROBOT-ASSISTED VITREORETINAL SURGERY IMPROVES SURGICAL ACCURACY COMPARED WITH MANUAL SURGERY: A Randomized Trial in a Simulated Setting. Retina. 2020;40(11):2091-2098. doi:10.1097/IAE.0000000000002720
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- ↑ S. Tatinati, K. Nazarpour, W. T. Ang and K. C. Veluvolu, "Multidimensional Modeling of Physiological Tremor for Active Compensation in Handheld Surgical Robotics," in IEEE Transactions on Industrial Electronics, vol. 64, no. 2, pp. 1645-1655, Feb. 2017, doi: 10.1109/TIE.2016.2597119. keywords: {Delays;Computational modeling;Instruments;Three-dimensional displays;Adaptation models;Robots;Solid modeling;Extreme learning machines (ELMs);handheld robotics;multidimensional modeling;physiological tremor},
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