Effects of Pneumatic Vitreolysis on Macular Hole
- Conditions
- Full-thickness Macular Holes (MH)Vitreomacular Traction (VMT)
- Interventions
- Device: Intraocular gas (C3F8)
- Registration Number
- NCT03677869
- Lead Sponsor
- Jaeb Center for Health Research
- Brief 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.
- Detailed Description
The objective of this trial is to obtain estimates of the proportion of eyes with MH closure of the inner retinal layers for eyes with VMT and full-thickness MHs treated with PVL. Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary. Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pneumatic vitreolysis (PVL) Intraocular gas (C3F8) Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
- Primary Outcome Measures
Name Time Method Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy at 8 weeks
- Secondary Outcome Measures
Name Time Method No Macular Hole Closure Despite Rescue Vitrectomy 8 weeks Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline Baseline to 8 weeks Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
E-ETDRS Visual Acuity Letter Score 8 weeks Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Number of Eyes With Rescue Treatment Before the 8-week Visit up to 8 Weeks Macular Hole Closure Without Rescue Vitrectomy 8 Weeks Macular Hole Closure With Rescue Vitrectomy 8 weeks No Macular Hole Closure and no Rescue Vitrectomy 8 weeks
Trial Locations
- Locations (45)
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Mid-America Retina Consultants, P.A.
🇺🇸Overland Park, Kansas, United States
Retina-Vitreous Surgeons of Central New York, PC
🇺🇸Syracuse, New York, United States
Retina Associates of Sarasota
🇺🇸Sarasota, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
🇺🇸West Monroe, Louisiana, United States
University of Illinois at Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Southeastern Retina Associates
🇺🇸Chattanooga, Tennessee, United States
Charlotte Eye, Ear, Nose, and Throat Assoc., PA
🇺🇸Charlotte, North Carolina, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Vitreous Center
🇺🇸Edmond, Oklahoma, United States
Retina Associates of Cleveland, Inc.
🇺🇸Beachwood, Ohio, United States
Oregon Retina, LLP
🇺🇸Eugene, Oregon, United States
East Bay Retina Consultants, Inc.
🇺🇸Oakland, California, United States
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
Southern California Desert Retina Consultants, MC
🇺🇸Palm Desert, California, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Southeast Eye Institute, PA dba Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Gailey Eye Clinic
🇺🇸Bloomington, Illinois, United States
Illinois Retina Associates, SC
🇺🇸Oak Park, Illinois, United States
Southeast Retina Center, PC
🇺🇸Augusta, Georgia, United States
Thomas Eye Group
🇺🇸Sandy Springs, Georgia, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Raj K. Maturi, MD, PC
🇺🇸Indianapolis, Indiana, United States
Elman Retina Group, BA
🇺🇸Baltimore, Maryland, United States
Valley Eye Physicians and Surgeons
🇺🇸Ayer, Massachusetts, United States
Vitreo-Retinal Associates, PC
🇺🇸Worcester, Massachusetts, United States
Mayo Clinic Department of Ophthalmology
🇺🇸Rochester, Minnesota, United States
Retina Specialists of Michigan
🇺🇸Grand Rapids, Michigan, United States
MaculaCare
🇺🇸New York, New York, United States
Western Carolina Clinical Research, LLC
🇺🇸Asheville, North Carolina, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Retina Northwest, PC
🇺🇸Portland, Oregon, United States
Southeastern Retina Associates, PC
🇺🇸Knoxville, Tennessee, United States
Spokane Eye Clinic
🇺🇸Spokane, Washington, United States
Florida Retina Institute
🇺🇸Orlando, Florida, United States
University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr
🇺🇸Jacksonville, Florida, United States