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| Name | Class |
|---|---|
| NHS Grampian | OTHER_GOV |
| Chief Scientist Office of the Scottish Government | OTHER_GOV |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILM peeling | Active Comparator | Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with ILM peeling |
|
| No ILM peeling | Active Comparator | combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas without ILM peeling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrectomy, post hyaloid detachment and gas injection with or without ILM peel. | Procedure | Combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3, 6 and 24 months post surgery |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Noemi Lois | NHS Grampian | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Eye and Ear Hospital | Dublin | Ireland | ||||
| Waterford Regional Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21051731 | Derived | 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. | |
| 18980675 |
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| Waterford |
| Ireland |
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| D005740 | Gases |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D007287 | Inorganic Chemicals |
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