- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03525899
Macular Hole After Diabetic Vitrectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients had received initial vitrectomy to treat complications of PDR. Recruited patients were divided to two groups: the persistent MH group, who had MH before the primary DV (group 1); and the newly-developed MH group, who developed MH after a successful primary DV (group 2). The patients' demographic data, records of ophthalmological examinations, and surgical procedures were collected, including best-corrected visual acuity before and after each operation, fundus changes, as well as MH repairing techniques. The extent of fibrovascular proliferation(FVP) was separated into four grades based on the severity of vitreoretinal adhesion : multiple-point adhesions with or without one site plaque-like broad adhesion (grade 1), broad adhesions in more than one but fewer than three sites, located posterior to the equator (grade 2), broad adhesions in more than three sites, located posterior to the equator or extending beyond the equator within one quadrant (grade 3), and broad adhesions extending beyond the equator for more than one quadrant (grade 4). The extent of retinal detachment (RD) was classified into "within the arcade" or "beyond the arcade". The macular structure was evaluated by optical coherence tomography (OCT). All patients had a follow-up duration of more than three months after the final surgical procedures.
Three different surgical techniques were used to treat MH: standard internal limiting membrane (ILM) peeling, inverted ILM flap insertion into the MH, and lens anterior or posterior capsular flap insertion into the MH. The indication(s) for each technique were:
standard ILM peeling was performed if no ILM peeling had been done in the previous surgery, and the MH size was less than 500um in an attached retina; inverted ILM flap insertion was performed if no ILM peeling had been done in the previous surgery, with a detached retina; lens anterior capsule flap insertion was performed if cataract surgery was performed in the same setting with no ILM tissue available; lens posterior capsule flap insertion was performed in a pseudophakic eye with no ILM tissue available. Only descriptive statistics was obtained.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan, 100
- Department of Ophthalmology, National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Proliferative diabetic retinopathy patients presenting with macular hole after primary diabetic vitrectomy
- The persistent MH group after surgery, who had MH before the primary DV
- Newly-developed MH group, who developed MH after a successful primary diabetic retinopathy
Exclusion Criteria:
- Patients with peripheral breaks
- Patients with macular hole before surgery, which closed after primary diabetic retinopathy
- Missing clinical data
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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MH after diabetic pars plana vitrectomy
Recruited patients included, the persistent MH group, who had MH before the primary DV, and the newly-developed MH group, who developed MH after a successful primary DV
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Pars plana vitrectomy combined with Internal limiting membrane peeling, inverted internal limiting membrane flap insertion into the macular hole, or lens anterior or posterior capsular flap insertion into the macular hole
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to macular hole closure
Time Frame: OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year
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Evaluation by optical coherence tomography
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OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected visual acuity
Time Frame: One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.
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Landolt C chart
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One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.
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Collaborators and Investigators
Investigators
- Study Director: Chung-May Yang, MD, National Taiwan University Hospital
Publications and helpful links
General Publications
- Yeh PT, Cheng CK, Chen MS, Yang CH, Yang CM. Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation. Retina. 2009 Mar;29(3):355-61. doi: 10.1097/IAE.0b013e31818c3251.
- Chen SN, Yang CM. LENS CAPSULAR FLAP TRANSPLANTATION IN THE MANAGEMENT OF REFRACTORY MACULAR HOLE FROM MULTIPLE ETIOLOGIES. Retina. 2016 Jan;36(1):163-70. doi: 10.1097/IAE.0000000000000674.
- Ghoraba H. Types of macular holes encountered during diabetic vitrectomy. Retina. 2002 Apr;22(2):176-82. doi: 10.1097/00006982-200204000-00007.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201709039RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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