Effects of Pneumatic Vitreolysis on Vitreomacular Traction (NCT03647267) | Clinical Trial Compass
CompletedPhase 3
Effects of Pneumatic Vitreolysis on Vitreomacular Traction
United States46 participantsStarted 2018-10-16
Plain-language summary
Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.
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
✓. At least one eye meets the study eye criteria listed below.
✓. 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 wear wristband that informs any medical personnel that the patient has a gas bubble in the eye
Exclusion criteria
✕. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that might preclude completion of follow-up)
✕. Participation in an investigational trial within 30 days of randomization that involves treatment with any drug or device that has not received regulatory approval for the indication being studied at the time of study entry
✕. Known contraindication to any component of the treatment
✕. Known allergy to any drug used in the procedure prep (including povidone iodine)
✕0. Potential participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months following randomization
✕1. Anticipated surgery requiring anesthesia within the next 6 months following randomization
What they're measuring
1
Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy
✕2. For women of child-bearing potential, pregnant at the time of enrollment
✕. 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 Note: presence of epiretinal membrane is neither a requirement nor exclusion.