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

Primary Purpose

Stage 2 or 3 Full Thickness Macular Hole

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage 2 or 3 Full Thickness Macular Hole focused on measuring Full thickness macular hole, Internal limiting membrane (ILM), Vitreo retinal surgery, Vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Victoria Eye and Ear Hospital
  • Waterford Regional Hospital
  • Aberdeen Royal Infirmary
  • Bristol Eye Hospital
  • Ninewells Hospital
  • Gartnavel General Hospital
  • Royal Liverpool Hospital
  • Oxford Eye Hospital
  • Sunderland Eye Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ILM peeling

No ILM peeling

Arm Description

Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with ILM peeling

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

Outcomes

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 2, 2006
Last Updated
June 5, 2012
Sponsor
University of Aberdeen
Collaborators
NHS Grampian, Chief Scientist Office of the Scottish Government
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1. Study Identification

Unique Protocol Identification Number
NCT00286507
Brief Title
Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
Collaborators
NHS Grampian, Chief Scientist Office of the Scottish Government

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage 2 or 3 Full Thickness Macular Hole
Keywords
Full thickness macular hole, Internal limiting membrane (ILM), Vitreo retinal surgery, Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ILM peeling
Arm Type
Active Comparator
Arm Description
Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with ILM peeling
Arm Title
No ILM peeling
Arm Type
Active Comparator
Arm Description
combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas without ILM peeling
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel.
Intervention Description
Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noemi Lois
Organizational Affiliation
NHS Grampian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Eye and Ear Hospital
City
Dublin
Country
Ireland
Facility Name
Waterford Regional Hospital
City
Waterford
Country
Ireland
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
Country
United Kingdom
Facility Name
Bristol Eye Hospital
City
Bristol
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Royal Liverpool Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Oxford Eye Hospital
City
Oxford
Country
United Kingdom
Facility Name
Sunderland Eye Infirmary
City
Sunderland
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21051731
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.
Results Reference
derived
PubMed Identifier
18980675
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.
Results Reference
derived

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Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study

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