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

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Sun Yat-sen University

Status

Completed

Conditions

High Myopia
Macular Holes
Macular Detachment

Treatments

Other: Gas tamponade
Procedure: Buckle
Other: Limbal paracentesis
Procedure: Vitrectomy
Other: Peeling internal limiting membrane
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)

50 participants in 2 patient groups

Buckle
Experimental group
Description:
Macular buckling, Limbal paracentesis, and intraocular gas injection.
Treatment:
Other: Gas injection
Other: Limbal paracentesis
Procedure: Buckle
Vitrectomy
Active Comparator group
Description:
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
Treatment:
Other: Peeling internal limiting membrane
Procedure: Vitrectomy
Other: Gas tamponade

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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