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

NCT ID: NCT03023800

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-10-12

Brief Summary

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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

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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.

Conditions

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Retinoschisis Macular Detachment High Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buckle

Macular buckling and intraocular gas (C3F8) injection.

Group Type EXPERIMENTAL

Macular buckling

Intervention Type PROCEDURE

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.

Vitrectomy

Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).

Group Type ACTIVE_COMPARATOR

Vitrectomy

Intervention Type PROCEDURE

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

Interventions

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Macular 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.

Intervention Type PROCEDURE

Vitrectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Lin Lu

Director of Fundus Disease Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Lu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2013meky013(2)

Identifier Type: -

Identifier Source: org_study_id