Effects of Pneumatic Vitreolysis on Macular Hole (NCT03677869) | Clinical Trial Compass
CompletedNot Applicable
Effects of Pneumatic Vitreolysis on Macular Hole
United States36 participantsStarted 2018-11-14
Plain-language summary
Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years
✓. At least one eye meets the study eye criteria
✓. Able and willing to provide informed consent
✓. Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks)
✓. For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks)
✓. Able and willing to position face down for at least 50% of the time for at least 4 days post-injection (to facilitate macular hole closure)
Exclusion criteria
✕. Full-thickness macular hole that is ≤ 250 microns at the narrowest point, confirmed by central reading center
✕. Vitreomacular adhesion on OCT that is no larger than 3000 microns with visible separation of the vitreous on either side as seen on horizontal and vertical scans , confirmed by central reading center
✕. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 83 (20/25 or worse) Exclusion
✕. Other ocular condition that might affect visual acuity during the course of the study or require intraocular treatment (e.g., retinal vein occlusion, substantial age-related macular degeneration, or macular edema induced by a condition other than VMT)
✕. High level of myopia (spherical equivalent of -8.00 diopters or more myopic if phakic, or retinal abnormalities consistent with pathologic myopia if phakic or pseudophakic)
What they're measuring
1
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy