Macular Hole After Diabetic Vitrectomy

NCT03525899 | Completed

• 1 other identifier: 201709039RINB
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Proliferative Diabetic Retinopathy; Macular Holes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Best corrected visual acuity

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

Study Arms (1)

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

Interventions

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

MH after diabetic pars plana vitrectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with peripheral breaks
• Patients with macular hole before surgery, which closed after primary diabetic retinopathy
• Missing clinical data

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 18997639 BACKGROUND

• 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.

  PMID: 26200509 BACKGROUND

• Ghoraba H. Types of macular holes encountered during diabetic vitrectomy. Retina. 2002 Apr;22(2):176-82. doi: 10.1097/00006982-200204000-00007.

  PMID: 11927850 BACKGROUND

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Chung-May Yang, MD

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: May 16, 2018
• Study Start: November 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 16, 2018

Record last verified: 2017-10

Locations

TW (1)