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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03023800

Collaborator

(none)

Enrollment

Location

Arms

30.4

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinoschisis Macular Detachment High Myopia	Procedure: Macular buckling Procedure: Vitrectomy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jan 30, 2017

Actual Study Completion Date :

Oct 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buckle Macular buckling and intraocular gas (C3F8) injection.	Procedure: 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.
Active Comparator: Vitrectomy Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).	Procedure: Vitrectomy Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia

Arm

Intervention/Treatment

Experimental: Buckle

Macular buckling and intraocular gas (C3F8) injection.

Procedure: 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.

Active Comparator: Vitrectomy

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

Procedure: Vitrectomy

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

Outcome Measures

Primary Outcome Measures

Retinal re-attachment rate [3 month]

Secondary Outcome Measures

Post-operative best corrected visual acuity [12 month]
Post-operative macular structure on optical coherance tomography [12 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Lin Lu, MD，PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lin Lu, Director of Fundus Disease Center, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03023800

Other Study ID Numbers:

2013meky013(2)

First Posted:

Jan 18, 2017

Last Update Posted:

Oct 16, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Myopia

Retinoschisis

Dissociative Disorders

Study Results

No Results Posted as of Oct 16, 2017