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
• Interventions: Procedure: Vitrectomy; Procedure: Macular buckling

• 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

Arm && Interventions

Group	Intervention	Description
Vitrectomy	Vitrectomy	Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).
Buckle	Macular buckling	Macular buckling and intraocular gas (C3F8) injection.

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