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
• Interventions: Procedure: Buckle; Procedure: Vitrectomy; Other: Limbal paracentesis; Other: Peeling internal limiting membrane; Other: Gas injection; Other: Gas tamponade

• 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

Arm && Interventions

Group	Intervention	Description
Buckle	Buckle	Macular buckling, Limbal paracentesis, and intraocular gas injection.
Vitrectomy	Vitrectomy	Vitrectomy, peeling internal limiting membrane, and gas tamponade.
Buckle	Gas injection	Macular buckling, Limbal paracentesis, and intraocular gas injection.
Buckle	Limbal paracentesis	Macular buckling, Limbal paracentesis, and intraocular gas injection.
Vitrectomy	Peeling internal limiting membrane	Vitrectomy, peeling internal limiting membrane, and gas tamponade.
Vitrectomy	Gas tamponade	Vitrectomy, peeling internal limiting membrane, and gas tamponade.

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