Dataset Information

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).

ABSTRACT: BACKGROUND: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

SUBMITTER: Lois N

PROVIDER: S-EPMC2607251 | biostudies-literature | 2008 Nov

REPOSITORIES: biostudies-literature

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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).

Lois Noemi N Burr Jennifer J Norrie John J Vale Luke L Cook Jonathan J McDonald Alison A

Trials 20081103

<h4>Background</h4>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 impr ...[more]

PMID: 18980675

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Project description:BackgroundThe internal limiting membrane (ILM) insertion technique was widely used to treat large macular hole (MH) for the high closure rate. However, the prognosis of closed MH after ILM insertion compared to ILM peeling remains controversial. This study aimed to compare foveal microstructure and microperimeter in large idiopathic MH surgically closed by ILM peeling and ILM insertion.MethodsThis retrospective, non-randomized, comparative study included patients with idiopathic MH (minimum diameter ≥ 650 μm) who underwent primary pars plana vitrectomy (PPV) with ILM peeling or ILM insertion. The initial closure rate was recorded. Patients with initially closed MHs were divided into two groups according to the surgery methods. The best-corrected visual acuity (BCVA), optical coherence tomography (OCT) and microperimeter-3 (MP-3) outcomes of two groups were compared at baseline, 1 and 4 months postoperatively.ResultsFor idiopathic MH (minimum diameter ≥ 650 μm), ILM insertion had a significantly higher initial closure rate than ILM peeling (71.19% vs. 97.62%, P = 0.001). Among 39 patients with initially closed MHs who were on regular follow-up, twenty-one were assigned to the ILM peeling group and 18 to the ILM insertion group. Postoperative BCVA improved significantly in both groups. The final BCVA (logMAR) (0.40 vs. 0.88, P < 0.001), macular hole sensitivity (19.66 dB vs. 14.14 dB, P < 0.001), peripheral sensitivity of macular hole (24.63 dB vs. 21.95 dB, P = 0.005), and fixation stability (FS) within 2 degrees (82.42% vs. 70.57%, P = 0.031) were significantly better and external limiting membrane (ELM) defect (330.14 μm vs. 788.28 μm, P < 0.001) and ellipsoid zone (EZ) defect (746.95 μm vs. 1105.11 μm, P = 0.010) were significantly smaller in the ILM peeling group than in the ILM insertion group.ConclusionFor initially closed MHs (minimum diameter ≥ 650 μm), both ILM peeling and ILM insertion significantly improved the microstructure and microperimeter in the fovea. However, ILM insertion was less efficient at microstructural and functional recovery after surgery.

Project description:To investigate visual field changes after vitrectomy for macular diseases in glaucomatous eyes.A retrospective review of 54 eyes from 54 patients with glaucoma, who underwent vitrectomy for epiretinal membrane (ERM; 42 eyes) or macular hole (MH; 12 eyes). Standard automated perimetry (Humphrey visual field 24-2 program) was performed and analyzed preoperatively and twice postoperatively (1st and 2nd sessions; 4.7 ± 2.5, 10.3 ± 3.7 months after surgery, respectively). Postoperative visual field sensitivity at each test point was compared with the preoperative value. Longitudinal changes in mean visual field sensitivity (MVFS) of the 12 test points within 10° eccentricity (center) and the remaining test points (periphery), best-corrected visual acuity (BCVA), intraocular pressure (IOP), and ganglion cell complex (GCC) thickness, and the association of factors with changes in central or peripheral MVFS over time were analyzed using linear mixed-effects models. In addition, 45 eyes from 45 patients without glaucoma who underwent vitrectomy for epiretinal membrane (ERM; 34 eyes) or macular hole (MH; 11 eyes) were similarly examined and statistically analyzed (control group).In glaucomatous eyes, visual field test points changed significantly and reproducibly; two points deteriorated only at the center and twelve points improved only at the periphery. Central MVFS decreased (p = 0.03), whereas peripheral MVFS increased postoperatively (p = 0.010). In the control group, no visual field test points showed deterioration, and central MVFS did not change significantly after vitrectomy. BCVA improved, GCC thickness decreased, and IOP did not change postoperatively in both groups. The linear mixed-effects models identified older age, systemic hypertension, longer axial length, and preoperative medication scores of ?2 as risk factors for central MVFS deterioration in glaucomatous eyes.Visual field sensitivity within 10° eccentricity may deteriorate after vitrectomy for ERM or MH in glaucomatous eyes.

Dataset Information

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).

Publications

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).

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