Clinical trial NCT00286507: Full Thickness Macular Hole and Internal Limiting Membrane Peeling 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage 2 or 3 Full Thickness Macular Hole
Keywords: Full thickness macular hole
Internal limiting membrane (ILM)
Vitreo retinal surgery
Vitrectomy
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
name: Chief Scientist Office of the Scottish Government
First posted: 2006-02-03
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months post surgery
Secondary outcomes:
measure: 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.
timeFrame: 3, 6 and 24 months post surgery
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Royal Victoria Eye and Ear Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Hospital
city: Oxford
country: United Kingdom
facility: Oxford Eye Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
affiliation: NHS Grampian
name: Noemi Lois
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lois N, Burr J, Norrie J, Vale L, Cook J, McDonald A, Boachie C, Ternent L, McPherson G; Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group. Internal limiting membrane peeling versus no peeling for idiopathic full-thickness macular hole: a pragmatic randomized controlled trial. Invest Ophthalmol Vis Sci. 2011 Mar 1;52(3):1586-92. doi: 10.1167/iovs.10-6287.
citation: Lois N, Burr J, Norrie J, Vale L, Cook J, McDonald A; Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group. Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a randomised controlled trial: FILMS (Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study). Trials. 2008 Nov 3;9:61. doi: 10.1186/1745-6215-9-61.