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

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ClinicalTrials.gov Identifier: NCT00286507
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : June 6, 2012
Sponsor:
Collaborators:
NHS Grampian
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Aberdeen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stage 2 or 3 Full Thickness Macular Hole Procedure: Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel. Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : July 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2011
Arms and Interventions
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Arm Intervention/treatment
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
 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: No ILM peeling
combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas without ILM peeling
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286507


Locations
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Ireland
Royal Victoria Eye and Ear Hospital
Dublin, Ireland
Waterford Regional Hospital
Waterford, Ireland
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, United Kingdom
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Chief Scientist Office of the Scottish Government
Investigators
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Principal Investigator: Noemi Lois NHS Grampian
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT00286507    
Other Study ID Numbers: CZH/4/235
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by University of Aberdeen:
Full thickness macular hole
Internal limiting membrane (ILM)
Vitreo retinal surgery
Vitrectomy
Additional relevant MeSH terms:
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Retinal Perforations
Retinal Diseases
Eye Diseases