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Clinical Trials/NCT03525899
NCT03525899
Completed
Not Applicable

Macular Hole After Diabetic Vitrectomy

National Taiwan University Hospital1 site in 1 country7 target enrollmentNovember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proliferative Diabetic Retinopathy
Sponsor
National Taiwan University Hospital
Enrollment
7
Locations
1
Primary Endpoint
Time to macular hole closure
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
December 1, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time to macular hole closure

Time Frame: OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year

Evaluation by optical coherence tomography

Secondary Outcomes

  • Best corrected visual acuity(One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.)

Study Sites (1)

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