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

Not Applicable

Completed

• Conditions: Macular Holes; High Myopia; Macular Detachment

• Registration Number: NCT03433547
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.

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 full-thickness macular hole associated with macular detachment in eyes with high myopia.

Study Timeline

• Study First Submitted: 2018-01-23
• Study Start: 2018-01-30
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Primary Completion: 2018-07-20
• Study Completion: 2018-08-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
• full-thickness macular hole
• macular retinal detachment
• evidence of posterior staphyloma on clinical examination

Exclusion Criteria

• macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
• a history of vitrectomy or scleral buckling
• 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	1 month	Successful rate of reattachment of macular retina after surgery

Secondary Outcome Measures

Name	Time	Method
Macular hole status	3 month	Closure rate of macular hole after surgery on optical coherence tomography
Post-operative best corrected visual acuity	3 month	Best corrected visual acuity of the eyes after surgery

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China