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dc.contributor.authorLois, Noemi
dc.contributor.authorBurr, Jennifer
dc.contributor.authorNorrie, John
dc.contributor.authorVale, Luke
dc.contributor.authorCook, Jonathan
dc.contributor.authorMcDonald, Alison
dc.contributor.authorFull-Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group
dc.date.accessioned2012-03-08T12:31:03Z
dc.date.available2012-03-08T12:31:03Z
dc.date.issued2008-11-03
dc.identifier.citationLois , N , Burr , J , Norrie , J , Vale , L , Cook , J , McDonald , A & Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study (FILMS) Group 2008 , ' 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 , vol. 9 , 61 , pp. - . https://doi.org/10.1186/1745-6215-9-61en
dc.identifier.issn1745-6215
dc.identifier.otherPURE: 16573651
dc.identifier.otherPURE UUID: 6660e578-0af1-4fbb-8738-4c268e2f7f00
dc.identifier.otherWOS: 000262116400001
dc.identifier.otherScopus: 58149091616
dc.identifier.otherORCID: /0000-0002-9478-738X/work/60196199
dc.identifier.urihttp://hdl.handle.net/10023/2410
dc.descriptionThis work is supported by funding from the Chief Scientist Office, Scotland (project ref no CZH/4/235)en
dc.description.abstractBackground: A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs) have demonstrated that surgery, by means of pars plana vitrectomy and post-operative intraocular tamponade with gas, is effective for stage 2, 3 and 4 FTMH. Internal limiting membrane (ILM) peeling has been introduced as an additional surgical manoeuvre to increase the success of the surgery; i.e. increase rates of hole closure and visual improvement. However, little robust evidence exists supporting the superiority of ILM peeling compared with no-peeling techniques. The purpose of FILMS (Full-thickness macular hole and Internal Limiting Membrane peeling Study) is to determine whether ILM peeling improves the visual function, the anatomical closure of FTMH, and the quality of life of patients affected by this disorder, and the cost-effectiveness of the surgery. Methods/Design: Patients with stage 2-3 idiopathic FTMH of less or equal than 18 months duration (based on symptoms reported by the participant) and with a visual acuity <= 20/40 in the study eye will be enrolled in this FILMS from eight sites across the UK and Ireland. Participants will be randomised to receive combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling. The primary outcome is distance visual acuity at 6 months. Secondary outcomes include distance visual acuity at 3 and 24 months, near visual acuity at 3, 6, and 24 months, contrast sensitivity at 6 months, reading speed at 6 months, anatomical closure of the macular hole at each time point (1, 3, 6, and 24 months), health related quality of life (HRQOL) at six months, costs to the health service and the participant, incremental costs per quality adjusted life year (QALY) and adverse events. Discussion: FILMS will provide high quality evidence on the role of ILM peeling in FTMH surgery.
dc.format.extent8
dc.language.isoeng
dc.relation.ispartofTrialsen
dc.rights© 2008 Lois et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.en
dc.subjectSurgeryen
dc.subjectVitrectomyen
dc.subjectMulticenteren
dc.subjectManagementen
dc.subjectRemovalen
dc.subjectR Medicine (General)en
dc.subject.lccR1en
dc.titleClinical 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)en
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.identifier.doihttps://doi.org/10.1186/1745-6215-9-61
dc.description.statusPeer revieweden
dc.identifier.urlhttp://www.trialsjournal.com/content/9/1/61en


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