Back to resultsEffects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes
Primary Purpose
Retinoschisis, Macular Detachment, High Myopia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Macular buckling
Vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Retinoschisis
Eligibility Criteria
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
Sites / Locations
- Zhongshan Ophthalmic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buckle
Vitrectomy
Arm Description
Macular buckling and intraocular gas (C3F8) injection.
Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).
Outcomes
Primary Outcome Measures
Retinal re-attachment rate
Secondary Outcome Measures
Post-operative best corrected visual acuity
Post-operative macular structure on optical coherance tomography
Full Information
NCT ID
NCT03023800
First Posted
January 16, 2017
Last Updated
October 12, 2017
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03023800
Brief Title
Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes
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 Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
October 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoschisis, Macular Detachment, High Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buckle
Arm Type
Experimental
Arm Description
Macular buckling and intraocular gas (C3F8) injection.
Arm Title
Vitrectomy
Arm Type
Active Comparator
Arm Description
Vitrectomy, internal limiting membrane peeling, and gas tamponade (C3F8).
Intervention Type
Procedure
Intervention Name(s)
Macular buckling
Intervention Description
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
Intervention Name(s)
Vitrectomy
Intervention Description
Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia
Primary Outcome Measure Information:
Title
Retinal re-attachment rate
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Post-operative best corrected visual acuity
Time Frame
12 month
Title
Post-operative macular structure on optical coherance tomography
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Lu, MD，PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes
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