Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study

Stage 2 or 3 Full Thickness Macular Hole Clinical Trial

— FILMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286507
• Other study ID #: CZH/4/235
• Status: Completed
• Phase: N/A
• First received: February 2, 2006
• Last updated: June 5, 2012
• Start date: July 2005
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: September 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Perforations
• Stage 2 or 3 Full Thickness Macular Hole

Intervention

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

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Aberdeen	Chief Scientist Office of the Scottish Government, NHS Grampian

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months post surgery	No
Secondary	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.		3, 6 and 24 months post surgery	Yes