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Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study

NCT00286507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2012-06-06

No results posted yet for this study

Summary

A macular hole is a fairly common problem in the retina and is an important cause of loss of central vision. The aim of this study is to determine whether, in patients with a stage 2 or 3 full thickness macular hole (FTMH), peeling a very fine, transparent tissue that covers the surface of the retina, called the internal limiting membrane (ILM) during surgery is superior to non-ILM peeling macular hole surgery. The main outcomes are improvement in vision, achievement of macular hole closure, need for re-operation, health related quality of life (HRQOL) and cost effectiveness.

Conditions

  • Stage 2 or 3 Full Thickness Macular Hole

Interventions

PROCEDURE

Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.

Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling

Sponsors & Collaborators

  • NHS Grampian

    collaborator OTHER_GOV

  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Noemi Lois · NHS Grampian

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-09-30
Completion
2011-09-30

Countries

  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00286507 on ClinicalTrials.gov