Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study - Full Text View

Sponsors and Collaborators:	University of Aberdeen NHS Grampian Chief Scientist's Office of the Scottish Executive
Information provided by:	University of Aberdeen
ClinicalTrials.gov Identifier:	NCT00286507

Purpose

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.

Condition	Intervention
Stage 2 or 3 Full Thickness Macular Hole	Procedure: Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study: Randomised Comparison of Macular Hole Surgery With or Without Internal Limiting Membrane Peeling

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:

The primary outcome of the study is the mean difference between treatment groups in the Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity score at 6 months post surgery.

Secondary Outcome Measures:

Secondary outcomes include anatomical closure, adverse events, re-operation, distance visual acuity (VA), near VA, contrast sensitivity and reading speed at 6 months, costs to the health service and the participant and HRQOL at six months.

Estimated Enrollment:	150
Study Start Date:	July 2005
Estimated Study Completion Date:	September 2009

Detailed Description:

Idiopathic full-thickness macular hole (FTMH) is an important cause of loss of central vision, usually leading to severe visual impairment. Up to 20% of affected people will develop a FTMH in both eyes. There is uncertainty in the literature and among vitreo-retinal surgeons about the balance of potential benefits and adverse effects of ILM peeling in FTMH surgery for stage 2-3 holes.

FILMS is a randomised controlled trial (RCT) in patients with stage 2-3 FTMH less less than 18 months duration investigating whether ILM peeling improves the anatomical and visual outcome of macular hole surgery and the quality of life of patients with this retinal disease. Cost-effectiveness is also being addressed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Idiopathic FTMH of stage 2-3, Duration of hole ≤18 months, Visual acuity equal to or worse than 20/40 in the study eye.

Exclusion Criteria:

Stage 1 or 4 FTMH, Stage 2-3 FTMH of > 18 months duration, Visual acuity >20/40 in study eye, FTMH related to high myopia (>6 dioptres), FTMH related to trauma, any other causes of decreased vision (ie corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects present), patient unable to understand English, patient unable to give informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286507

Locations

Ireland
Waterford Regional Hospital
Waterford, Ireland
Royal Victoria Eye and Ear Hospital
Dublin, Ireland
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Royal Liverpool Hospital
Liverpool, United Kingdom
Oxford Eye Hospital
Oxford, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Bristol Eye Hospital
Bristol, United Kingdom
Sunderland Eye Infirmary
Sunderland, United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom

Sponsors and Collaborators

University of Aberdeen

NHS Grampian

Chief Scientist's Office of the Scottish Executive

Investigators

Principal Investigator:

Noemi Lois

NHS Grampian

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CZH/4/235
Study First Received:	February 2, 2006
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00286507 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:

Full thickness macular hole
Internal limiting membrane (ILM)
Vitreo retinal surgery
Vitrectomy

Study placed in the following topic categories:

Eye Diseases
Retinal Perforations
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Perforations
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009