Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Completed · Phase 3 · Has a placebo group

Conditions studied: Vitreomacular Traction

In brief

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.

Key facts

Study ID

NCT03647267

Run by

Jaeb Center for Health Research

People needed

46

Starts

2018-10-16

Expected to finish

2020-08-06

Last updated by the study team

2022-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• A potential participant is not eligible if any of the following exclusion criteria are present:
• 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
• Note: study participants should not receive another investigational drug/device while participating in the study
• Known contraindication to any component of the treatment
• Known allergy to any drug used in the procedure prep (including povidone iodine)
• 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
• Anticipated surgery requiring anesthesia within the next 6 months following randomization
• Participants cannot receive nitrous oxide until gas resolution
• For women of child-bearing potential, pregnant at the time of enrollment
• Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgement may be used to determine when a pregnancy test is needed.
• Study Eye Criteria
• The participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.
• A participant can have only one study eye. If both eyes are eligible at the time of randomization, the study eye will be selected by the investigator and participant before randomization.
• The eligibility criteria for a study eye are as follows:
• Inclusion
• 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.
• Decreased visual function (e.g. metamorphopsia or other visual symptom) that is attributed to VMT.
• Examples of visual symptoms include:

Where it is running

• Retinal Diagnostic Center — Campbell, California, United States
• Atlantis Eye Care — Huntington Beach, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• East Bay Retina Consultants, Inc — Oakland, California, United States
• Southern California Desert Retina Consultants, MC — Palm Desert, California, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr — Jacksonville, Florida, United States
• Florida Retina Consultants — Lakeland, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Southeast Eye Institute, PA dba Eye Associates of Pinellas — Pinellas Park, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Southeast Retina Center, PC — Augusta, Georgia, United States
• Thomas Eye Group — Sandy Springs, Georgia, United States
• Gailey Eye Clinic — Bloomington, Illinois, United States
• University of Illinois at Chicago Medical Center — Chicago, Illinois, United States
• Illinois Retina Associates, S.C. — Oak Park, Illinois, United States
• Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Mid-America Retina Consultants, P.A. — Overland Park, Kansas, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Eye Associates of Northeast Louisiana dba Haik Humble Eye Center — West Monroe, Louisiana, United States
• Elman Retina Group, PA — Baltimore, Maryland, United States
• Valley Eye Physicians and Surgeons — Ayer, Massachusetts, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Vitreo-Retinal Associates, PC — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.