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See also comment(s) by David Friedman •
PURPOSE: To report the vision-specific quality of life (QoL) outcomes in the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial METHODS: Setting: 17 clinical centers Study population: Patients 18 to 85 years of age with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. INTERVENTIONS: Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with MMC. MAIN OUTCOME MEASURES: Vision-specific QoL using the NEI VFQ-25 and estimation of minimally important differences (MID) were the main outcome measures. Cross-sectional distribution- and anchor-based approaches were used to estimate MID. Clinical anchor measures included the mean deviation (MD) and logMAR visual acuity (VA) measurements. Clinically significant changes in anchor were defined as > 2 dB MD and > 0.2 logMAR. RESULTS: No significant differences in composite scores were observed between treatment groups, and no significant change in scores were seen over time. Mean [SD; range] values of clinical anchors at baseline were -16.6 [9.3; -32 to -0.5] dB for the surgical eye, and 0.2 [0.3; -0.1 to 1.3] logMAR VA in the better vision eye. For anchor-based cross sectional analysis, composite score MID [95%CI] was 6.3 [4.6 to 7.9] for better eye VA and 1.4 [0.9 to 1.9] for surgical eye MD. Distribution-based MID for the composite score was 6.0. CONCLUSIONS: Trabeculectomy and tube shunt surgery had similar impact on patient reported vision-specific QoL measured using the NEI VFQ-25. In this cohort of patients with advanced glaucoma, MIDs varied depending on the clinical anchor used. Distribution based MIDs corresponded well with anchor-based MIDs based on VA measures. The MID values reported here may be useful for others wishing to interpret NEI VFQ-25 scores in their advanced glaucoma patient cohort.
NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK. Electronic address: aachal.kotecha@moorfields.nhs.uk.
Full article1.4 Quality of life (Part of: 1 General aspects)
12.8.1 Without tube implant (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)