Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Stage 2 or 3 Full Thickness Macular Hole |
Procedure: Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
- 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 ]
- 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 ]
| Enrollment: | 141 |
| Study Start Date: | July 2005 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Principal Investigator: | Noemi Lois | NHS Grampian |
More Information
Additional Information:
No publications provided by University of Aberdeen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Aberdeen |
| ClinicalTrials.gov Identifier: | NCT00286507 History of Changes |
| Other Study ID Numbers: | CZH/4/235 |
| Study First Received: | February 2, 2006 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Aberdeen:
|
Full thickness macular hole Internal limiting membrane (ILM) Vitreo retinal surgery Vitrectomy |
Additional relevant MeSH terms:
|
Retinal Perforations Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013