Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes

Not Applicable

Completed

• Conditions: Macular Detachment; Retinoschisis; High Myopia

• Registration Number: NCT03023800
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-16
• Study First Posted: 2017-01-18
• Primary Completion: 2017-01-30
• Status Verified: 2017-10
• Study Completion: 2017-10-12
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retinal re-attachment rate	3 month

Secondary Outcome Measures

Name	Time	Method
Post-operative best corrected visual acuity	12 month
Post-operative macular structure on optical coherance tomography	12 month

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China