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OpenTrials
Completed

NCT Number: NCT03525899

Macular Hole After Diabetic Vitrectomy

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pars plana vitrectomy

Procedure

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

Primary outcomes

  1. 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

  1. 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.

    Landolt C chart

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 16, 2018
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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