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

A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03433547

Enrollment

Registered

2018-02-14

Start date

2018-01-30

Completion date

2018-08-20

Last updated

2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia, Macular Detachment, Macular Holes

Keywords

macular buckling, full-thickness macular hole, macular detachment, internal limiting membrane peeling, high myopia

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.

Interventions

PROCEDUREBuckle

Surgical procedures of macular buckling

PROCEDUREVitrectomy

Surgical procedures of small gauge vitrectomy

OTHERLimbal paracentesis

Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis

OTHERGas injection

Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.

OTHERPeeling internal limiting membrane

Peeling internal limiting membrane with forceps

OTHERGas tamponade

Filling the vitreous cavity with gas (C3F8, 14%)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Retinal re-attachment rate	1 month	Successful rate of reattachment of macular retina after surgery

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026