Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment (ILMFCMHRDPDR)
Primary Purpose
Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ILM flaps insertion techniques or free ILM flaps.
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring macular hole, retinal detachment, PDR
Eligibility Criteria
Inclusion Criteria:
- Patients were proliferative diabetic retinopathy suffering from MH with RD.
Exclusion Criteria:
- Patients were not proliferative diabetic retinopathy suffering from MH with RD.
Sites / Locations
- Changhua Christian Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient accept surgery
Arm Description
Proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.
Outcomes
Primary Outcome Measures
Wilcoxon Sign-Rank test
A statistical comparison of average of two dependent samples
Secondary Outcome Measures
Full Information
NCT ID
NCT03618498
First Posted
July 23, 2018
Last Updated
August 7, 2018
Sponsor
Changhua Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03618498
Brief Title
Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment
Acronym
ILMFCMHRDPDR
Official Title
Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment in Eyes of Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose: To evaluate the logical surgical approaches in closing macular holes in eyes of proliferative diabetic retinopathy with retinal detachment
Detailed Description
High MH closure rate can be achieved. Other than high myopia, MH with RD may appear in several conditions, such as severe vitreomacular traction, proliferative diabetic retinopathy (PDR).clinical charts were reviewed of patients of proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.Standard 3-port 23 or 25 gauged pars plana vitrectomy was performed. After core vitrectomy, anterior-posterior oriented tractions as well as all fibrovascular tissues were removed as thoroughly as possible.The patients were kept in a facedown position overnight and were allowed to take any positions except supine for approximately one week.Various surgical approaches utilizing in managing macular hole may effectively closing macular holes and reattach retina.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
macular hole, retinal detachment, PDR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A 25-gauged blunt-tipped needle connected with Viscoat® (Alcon laboratories, Fort Worth, TX, USA) containing syringe was placed within the macular hole just below the level of the macular hole. A small amount of Viscoat® was injected into and around the hole. An ICG solution (25 mg ICG in 15 ml 5% glucose-water solution, final concentration = 1.7 mg/ml) was then carefully applied around the macular hole within the arcade.Excessive ICG was immediately removed by suction. ILM at the parafoveal area was peeled in a circular fashion. Care was taken not to peel the ILM flap across the hole edge. If possible, at least 1.5 to 2 disc area of partially detached ILM around the hole was left in place with central part remained attached to the edge of the hole.
Masking
None (Open Label)
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient accept surgery
Arm Type
Other
Arm Description
Proliferative diabetic retinopathy suffering from MH with RD who were treated with vitrectomy combined with inverted epiretinal ILM flap,inverted ILM flaps insertion techniques, or free ILM flaps.
Intervention Type
Procedure
Intervention Name(s)
ILM flaps insertion techniques or free ILM flaps.
Intervention Description
The ILM flap anchoring on the hole edge was inverted and covered the hole.Otherwise, temporal side ILM flap was used. However, if the risk of ILM flipping back was judged to be high, ILM insertion instead of ILM hole coverage was adopted.If the size of the ILM flaps was judged inadequate, the double ILM insertion technique was used, done by adding a piece of previously obtained free ILM flap on top of the inverted ILM tissue until they were securely in place.
Primary Outcome Measure Information:
Title
Wilcoxon Sign-Rank test
Description
A statistical comparison of average of two dependent samples
Time Frame
Baseline, 12 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients were proliferative diabetic retinopathy suffering from MH with RD.
Exclusion Criteria:
Patients were not proliferative diabetic retinopathy suffering from MH with RD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen San-Ni, MD
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Internal Limiting Membrane Flaps for Coexistent Macular Hole and Retinal Detachment
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