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

Sun Yat-sen University

Status: Completed

Conditions: High Myopia; Macular Holes; Macular Detachment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03433547

2013meky013-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Buckle

Experimental group

Description:

Macular buckling, Limbal paracentesis, and intraocular gas injection.

Treatment:

Other: Gas injection

Procedure: Buckle

Other: Limbal paracentesis

Vitrectomy

Active Comparator group

Description:

Vitrectomy, peeling internal limiting membrane, and gas tamponade.

Treatment:

Procedure: Vitrectomy

Other: Gas tamponade

Other: Peeling internal limiting membrane