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).

Study Overview

• Status: Completed
• Conditions: Proliferative Diabetic Retinopathy; Macular Holes
• Intervention / Treatment: Procedure: Pars plana vitrectomy

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: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Department of Ophthalmology, National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients from January 2010 to May 2017 treated by a single surgeon (Y.C.M) at National Taiwan University Hospital were retrospectively reviewed.

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Pars plana vitrectomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to macular hole closure	Evaluation by optical coherence tomography	OCT was performed monthly after operation, until MH closure was achieved, up yo 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Landolt C chart	One month after operation, and then the visual acuity was checked every six months. Up to 3.5 years.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• 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): November 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 8, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Retinal Perforations
• Other Study ID Numbers: 201709039RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No