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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2017
CompletedOctober 16, 2017
October 1, 2017
1.8 years
January 16, 2017
October 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Retinal re-attachment rate
3 month
Secondary Outcomes (2)
Post-operative best corrected visual acuity
12 month
Post-operative macular structure on optical coherance tomography
12 month
Study Arms (2)
Buckle
EXPERIMENTALMacular buckling and intraocular gas (C3F8) injection.
Vitrectomy
ACTIVE COMPARATORVitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).
Interventions
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.
Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Lu, MD，PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Fundus Disease Center
Study Record Dates
First Submitted
January 16, 2017
First Posted
January 18, 2017
Study Start
April 1, 2015
Primary Completion
January 30, 2017
Study Completion
October 12, 2017
Last Updated
October 16, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share