Trial reportRomanian journal of ophthalmology
Surgery for epiretinal membrane using three different surgical platforms: A comparative pilot study.
Trial report in Romanian journal of ophthalmology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To compare dye-assisted epiretinal membrane (ERM) peeling using a standard operating microscope (SOM) with peeling without staining using either microscope-integrated optical coherence tomography (Mi-OCT) or a three-dimensional heads-up display (3D-HUD) platform. Materials and methods: A prospective, randomized, and interventional pilot study. Patients requiring surgical intervention for ERM were randomized into group A (Mi-OCT), group B (3D-HUD), where dye was not used, and group C (dye-assisted peeling using SOM). Primary outcomes included the percentage of the eyes where complete ERM removal was possible without staining in groups A and B, intraoperative and postoperative complications, and best-corrected visual acuity (BCVA) at 3 months follow-up. Secondary outcomes included total surgical and ERM peel time. Results: Complete ERM peeling was possible only in 80% (group A) and 70% (group B) without using dye. Postoperatively, no ERM recurrence was observed in groups A and B, except for one (10%) in group C. BCVA at 3 months improved significantly from baseline in all. The mean surgical and ERM peel time was considerably lesser in groups A and B than in group C. Discussion: Mi-OCT and 3D-HUD ensured complete ERM removal in 80% and 70% of cases, respectively, without dye, compared to 100% in the conventional group, with one recurrence. Both technologies reduced surgical and peeling time. Intraoperative OCT improved visualization and minimized unnecessary maneuvers, aligning with PIONEER and DISCOVER studies. BCVA improved significantly at three months across all groups, with no intergroup differences. Despite benefits, high costs and a learning curve limit widespread adoption. Our study's small sample size and short follow-up warrant further research to validate findings and assess long-term outcomes, including potential dye-related toxicity in conventional techniques. Conclusion: Mi-OCT and 3D-HUD were associated with shorter surgical times and less need for staining. However, they had no added advantage over SOM at the three-month follow-up.
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