Completed

NCT Number: NCT00286507

Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study

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.

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Key information

Conditions

Stage 2 or 3 Full Thickness Macular Hole

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Eye and Ear Hospital, Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Procedure

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

Primary outcomes

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.

Time frame: 6 months post surgery

Secondary outcomes

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

Time frame: 3, 6 and 24 months post surgery

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

Chief Scientist Office of the Scottish Government
NHS Grampian

Registry information

Official study title

Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study: Randomised Comparison of Macular Hole Surgery With or Without Internal Limiting Membrane Peeling

Acronym: FILMS

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2011
First posted: Feb 3, 2006
Registry last updated: Jun 6, 2012

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.