#VMT RETINA TRIAL#

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)

An eye that requires prompt treatment for VMT should not be enrolledĮxclusion e.

Investigator and participant willing to wait 6 months before surgical intervention, provided visual acuity remains stable Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 78 (20/32 or worse) d. metamorphopsia or other visual symptom) that is attributed to VMT.Ī) Distortion and/or reduction in visual acuity b) Recognized difficulty with reading, driving, or using a computer c) Patient recognized interference with quality of life because of a and/or b.Ĭ.

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.

The eligibility criteria for a study eye are as follows: If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and participant before randomization. The participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.Ī participant can have only one study eye. Investigator judgement may be used to determine when a pregnancy test is needed.

Women who are potential study participants should be questioned about the potential for pregnancy.

Participants cannot receive nitrous oxide until gas resolutionįor women of child-bearing potential, pregnant at the time of enrollment.

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 randomizationĪnticipated surgery requiring anesthesia within the next 6 months following randomization.

Known allergy to any drug used in the procedure prep (including povidone iodine).

Known contraindication to any component of the treatment.

Note: study participants should not receive another investigational drug/device while participating in the study.

#VMT RETINA TRIAL#

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 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).For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks).Īble and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eyeĪ potential participant is not eligible if any of the following exclusion criteria are present:.Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks).Able and willing to provide informed consent.At least one eye meets the study eye criteria listed below.Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction Investigators and study coordinators are not masked to treatment group.

The goal is for study participants to remain masked to their treatment group assignment, although it is likely that the gas bubble will be visible to participants in the pneumatic vitreolysis group. Visual acuity and optical coherence tomography technicians will be masked to treatment group at all visits. Triple (Participant, Care Provider, Outcomes Assessor) Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Why Should I Register and Submit Results?.

Vmt retina