Abstract
Purpose: To evaluate pneumatic vitreolysis (PVL) in eyes with vitreomacular traction (VMT) with and without full-thickness macular hole (FTMH). Design: Two multicenter (28 sites) studies: a randomized clinical trial comparing PVL with observation (sham injection) for VMT without FTMH (Protocol AG) and a single-arm study assessing PVL for FTMH (Protocol AH). Participants: Participants were adults with central VMT (vitreomacular adhesion was ≤3000 μm). In Protocol AG, visual acuity (VA) was 20/32 to 20/400. In Protocol AH, eyes had a FTMH (≤250 μm at the narrowest point) and VA of 20/25 to 20/400. Methods: Pneumatic vitreolysis using perfluoropropane (C3F8) gas. Main Outcome Measures: Central VMT release at 24 weeks (Protocol AG) and FTMH closure at 8 weeks (Protocol AH). Results: From October 2018 through February 2020, 46 participants were enrolled in Protocol AG, and 35 were enrolled in Protocol AH. Higher than expected rates of retinal detachment and tear resulted in early termination of both protocols. Combining studies, 7 of 59 eyes (12% [95% CI, 6%–23%]; 2 eyes in Protocol AG, 5 eyes in Protocol AH) that received PVL developed rhegmatogenous retinal detachment (n = 6) or retinal tear (n = 1). At 24 weeks in Protocol AG, 18 of 23 eyes in the PVL group (78%) versus 2 of 22 eyes in the sham group (9%) achieved central VMT release without rescue vitrectomy (adjusted risk difference, 66% [95% CI, 44%–88%]; P< 0.001). The mean change in VA from baseline at 24 weeks was 6.7 letters in the PVL group and 6.1 letters in the sham group (adjusted difference, –0.8 [95% CI, –6.1 to 4.5]; P = 0.77). In Protocol AH, 10 of 35 eyes (29% [95% CI, 16%–45%]) achieved FTMH closure without rescue vitrectomy at 8 weeks. The mean change in VA from baseline at 8 weeks was –1.5 letters (95% CI, –10.3 to 7.3 letters). Conclusions: In most eyes with VMT, PVL induced hyaloid release. In eyes with FTMH, PVL resulted in hole closure in approximately one third of eyes. These studies were terminated early because of safety concerns related to retinal detachments and retinal tears.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1592-1603 |
| Number of pages | 12 |
| Journal | Ophthalmology |
| Volume | 128 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2021 |
Funding
Supported by a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases , National Institutes of Health, Bethesda, Maryland (grant no.: UG1EY14231). Genentech provided use of and support for the myVisionTrack test software along with devices to operate myVisionTrack test. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. According to the Diabetic Retinopathy Clinical Research Retina Network Industry Collaboration Guidelines ( https://public.jaeb.org/drcrnet/view/Investig_Info ), the Diabetic Retinopathy Clinical Research Retina Network had complete control over the design of the protocol, ownership of the data, all editorial content of presentation and publication related to the protocol, and the decision to submit the manuscript for publication. The National Institutes of Health participated in oversight of the conduct of the study and review of the manuscript, but not directly in the design or conduct of the study; nor in the collection, management, analysis, or interpretation of the data; nor in the preparation of the manuscript. Adam R. Glassman had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Keywords
- CF
- DRCR Retina Network
- Pneumatic vitreolysis
- Vitreomacular traction macular hole
ASJC Scopus subject areas
- Ophthalmology