Effects of Pneumatic Vitreolysis on Macular Hole
- Conditions
- Full-thickness Macular Holes (MH)Vitreomacular Traction (VMT)
- 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
- 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 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 No Macular Hole Closure Despite Rescue Vitrectomy 8 weeks
Related Research Topics
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Trial Locations
- Locations (45)
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
Scroll for more (35 remaining)Retinal Diagnostic Center🇺🇸Campbell, California, United States