A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinoschisis
- Sponsor
- Sun Yat-sen University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Retinal re-attachment rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.
Detailed Description
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.
Investigators
Lin Lu
Director of Fundus Disease Center
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- •macular schisis
- •macular retinal detachment
- •evidence of posterior staphyloma on clinical examination
Exclusion Criteria
- •severe macular scar
- •macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- •prominent vitreomacular traction
- •a history of vitrectomy or macular buckle
- •intraocular active hemorrhage or inflammation
- •any media opacity which precluded imaging or clinical evaluation of the macula
Outcomes
Primary Outcomes
Retinal re-attachment rate
Time Frame: 3 month
Secondary Outcomes
- Post-operative best corrected visual acuity(12 month)
- Post-operative macular structure on optical coherance tomography(12 month)