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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Eyes With Central Vitreomacular Traction Release Without Rescue Vitrectomy
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
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.