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Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS)

This study has been completed.
Sponsor:
Collaborators:
NHS Grampian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT00286507
First received: February 2, 2006
Last updated: June 5, 2012
Last verified: June 2012

February 2, 2006
June 5, 2012
July 2005
September 2009   (final data collection date for primary outcome 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. [ Time Frame: 6 months post surgery ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00286507 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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.
Not Provided
Not Provided
 
Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study
Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study: Randomised Comparison of Macular Hole Surgery With or Without Internal Limiting Membrane Peeling

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Stage 2 or 3 Full Thickness Macular Hole
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
  • Active Comparator: ILM peeling
    Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with ILM peeling
    Intervention: Procedure: Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.
  • Active Comparator: No ILM peeling
    combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas without ILM peeling
    Intervention: Procedure: Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.
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. Print 2011 Mar.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
September 2011
September 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   United Kingdom
 
NCT00286507
CZH/4/235
Not Provided
University of Aberdeen
University of Aberdeen
  • NHS Grampian
  • Chief Scientist Office of the Scottish Government
Principal Investigator: Noemi Lois NHS Grampian
University of Aberdeen
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP