Subretinal injection is a method for gene delivery to treat genetic diseases of the photoreceptors and retinal pigment epithelium. A reflux-free subretinal injection is important to allow effective, safe, and cost-effective gene therapy to the retina. We report on a comparison between manual and robotic assistance in simulated subretinal injections using an artificial retina model. Nine surgeons carried out the procedure with and without the Preceyes Surgical System, using an OPMI Lumera 700 Zeiss surgical microscope equipped with intra-operative optical coherence tomography. Success in creating a bleb without reflux, injection duration, drift, tremor, and increase in the diameter of the puncture hole were analyzed. Robotic assistance improved drift (median 16 vs 212 µm), tremor (median 1 vs 18 µm), enlargement of the retinal hole, and allowed for prolonged injection times (median 52 vs 29 sec). Robotic assistance allowed higher rate of bleb formation (8/9 vs 4/9 attempts) with a moderate reduction in reflux (7/9 vs 8/9 attempts) in this artificial model. Robotic assistance can significantly contribute to subretinal injections and provide quantifiable parameters in assessing surgical and clinical success of novel retinal gene therapies.
Background
The aim was to explore the feasibility and safety of performing common surgical steps in epiretinal membrane (ERM) peeling using the Preceyes Surgical System (PSS).
Methods
In a tertiary centre, 15 pseudophakic patients with an idiopathic ERM were randomised to robot‐assistance or manual surgery in a 2:1 ratio. In the robot‐assisted group, the following steps were performed using PSS: (1) staining the internal limiting membrane (ILM), (2) removal of the dye, (3) creating an ILM flap, (4) completing the peeling, (5) holding a light pipe and (6) fluid–air exchange. Primary outcome measures were feasibility and safety. Secondary outcome measures were duration, best‐corrected visual acuity (BCVA) and central retinal thickness (CRT). Moreover, the distance travelled by the instrument during peeling was assessed using motion tracking software.
Results
All steps performed with PSS were feasible with no clinical adverse events or complications. The surgical time was longer in the robot‐assisted group (mean 56 min, SD = 12 vs. 24 min, SD = 5). During the study, the duration of robot‐assisted surgeries decreased from 72 to 46 min. The distance travelled by the forceps was shorter in the robot‐assisted group (mean 403 mm, SD = 186 vs. 550 mm, SD = 134). BCVA and CRT improved equally in both groups.
Conclusions
This is the world's first randomised controlled trial on robotic surgery for ERM. Although more time‐consuming, we found that several surgical steps were feasible with assistance of the PSS.
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