Back to resultsEffects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
Primary Purpose
Macular Holes, High Myopia, Macular Detachment
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Buckle
Vitrectomy
Limbal paracentesis
Gas injection
Peeling internal limiting membrane
Gas tamponade
Sponsored by
About this trial
This is an interventional treatment trial for Macular Holes focused on measuring macular buckling, full-thickness macular hole, macular detachment, internal limiting membrane peeling, high myopia
Eligibility Criteria
Inclusion Criteria:
- axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- full-thickness macular hole
- macular retinal detachment
- evidence of posterior staphyloma on clinical examination
Exclusion Criteria:
- macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- a history of vitrectomy or scleral buckling
- intraocular active hemorrhage or inflammation
- any media opacity which precluded imaging or clinical evaluation of the macula
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buckle
Vitrectomy
Arm Description
Macular buckling, Limbal paracentesis, and intraocular gas injection.
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
Outcomes
Primary Outcome Measures
Retinal re-attachment rate
Successful rate of reattachment of macular retina after surgery
Secondary Outcome Measures
Macular hole status
Closure rate of macular hole after surgery on optical coherence tomography
Post-operative best corrected visual acuity
Best corrected visual acuity of the eyes after surgery
Full Information
NCT ID
NCT03433547
First Posted
January 23, 2018
Last Updated
October 8, 2018
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03433547
Brief Title
Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
Official Title
A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy on Full-thickness Macular Hole and Concurrent Macular Detachment in Eyes With Highly Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Full-thickness macular Hole associated with macular detachment is a one of the maculopathies of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling versus vitrectomy in a cohort of highly myopic eyes with this situation.
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 full-thickness macular hole 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
Macular Holes, High Myopia, Macular Detachment
Keywords
macular buckling, full-thickness macular hole, macular detachment, internal limiting membrane peeling, high myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buckle
Arm Type
Experimental
Arm Description
Macular buckling, Limbal paracentesis, and intraocular gas injection.
Arm Title
Vitrectomy
Arm Type
Active Comparator
Arm Description
Vitrectomy, peeling internal limiting membrane, and gas tamponade.
Intervention Type
Procedure
Intervention Name(s)
Buckle
Other Intervention Name(s)
Implantation of a device of macular buckling
Intervention Description
Surgical procedures of macular buckling
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Intervention Description
Surgical procedures of small gauge vitrectomy
Intervention Type
Other
Intervention Name(s)
Limbal paracentesis
Intervention Description
Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis
Intervention Type
Other
Intervention Name(s)
Gas injection
Intervention Description
Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.
Intervention Type
Other
Intervention Name(s)
Peeling internal limiting membrane
Intervention Description
Peeling internal limiting membrane with forceps
Intervention Type
Other
Intervention Name(s)
Gas tamponade
Intervention Description
Filling the vitreous cavity with gas (C3F8, 14%)
Primary Outcome Measure Information:
Title
Retinal re-attachment rate
Description
Successful rate of reattachment of macular retina after surgery
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Macular hole status
Description
Closure rate of macular hole after surgery on optical coherence tomography
Time Frame
3 month
Title
Post-operative best corrected visual acuity
Description
Best corrected visual acuity of the eyes after surgery
Time Frame
3 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
full-thickness macular hole
macular retinal detachment
evidence of posterior staphyloma on clinical examination
Exclusion Criteria:
macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
a history of vitrectomy or scleral buckling
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, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33397654
Citation
Zhao X, Li Y, Ma W, Lian P, Yu X, Chen S, Huang X, Liu B, Lu L. Macular buckling versus vitrectomy on macular hole associated macular detachment in eyes with high myopia: a randomised trial. Br J Ophthalmol. 2022 Apr;106(4):582-586. doi: 10.1136/bjophthalmol-2020-317800. Epub 2021 Jan 4.
Results Reference
derived
PubMed Identifier
32408387
Citation
Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
Results Reference
derived
Learn more about this trial
Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
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