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

A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03023800

Enrollment

Registered

2017-01-18

Start date

2015-04-30

Completion date

2017-10-12

Last updated

2017-10-16

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

Conditions

High Myopia, Macular Detachment, Retinoschisis

Brief summary

Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.

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 macular schisis associated with macular detachment in eyes with high myopia.

Interventions

PROCEDUREMacular buckling

Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.

PROCEDUREVitrectomy

Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia

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 * macular schisis * macular retinal detachment * evidence of posterior staphyloma on clinical examination

Exclusion criteria

* severe macular scar * macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant) * prominent vitreomacular traction * a history of vitrectomy or macular buckle * intraocular active hemorrhage or inflammation * any media opacity which precluded imaging or clinical evaluation of the macula

Design outcomes

Primary

Measure	Time frame
Retinal re-attachment rate	3 month

Secondary

Measure	Time frame
Post-operative best corrected visual acuity	12 month
Post-operative macular structure on optical coherance tomography	12 month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026