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Effects of Pneumatic Vitreolysis on Macular Hole

Not Applicable
Completed
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomyat 8 weeks
Secondary Outcome Measures
NameTimeMethod
Mean Change in E-ETDRS Visual Acuity Letter Score From BaselineBaseline 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 Score8 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 Visitup to 8 Weeks
Macular Hole Closure Without Rescue Vitrectomy8 Weeks
Macular Hole Closure With Rescue Vitrectomy8 weeks
No Macular Hole Closure and no Rescue Vitrectomy8 weeks
No Macular Hole Closure Despite Rescue Vitrectomy8 weeks

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

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