Aachal Kotecha1, William J Feuer2, Keith Barton3, Steven J Gedde2. 1. NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom. Electronic address: aachal.kotecha@moorfields.nhs.uk. 2. Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, Florida. 3. NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.
Abstract
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: Seventeen clinical centers. STUDY POPULATION: Patients 18-85 years of age with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. INTERVENTIONS:Tube shunt (350-mm2 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 (4.6-7.9) for better-eye VA and 1.4 (0.9-1.9) 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.
RCT Entities:
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: Seventeen clinical centers. STUDY POPULATION: Patients 18-85 years of age with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. INTERVENTIONS: Tube shunt (350-mm2 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 (4.6-7.9) for better-eye VA and 1.4 (0.9-1.9) 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 glaucomapatient cohort.
Authors: Anila Qasim; Tahira Devji; Mark R Phillips; Charles C Wykoff; Peter K Kaiser; Lehana Thabane; Mohit Bhandari; Varun Chaudhary Journal: Eye (Lond) Date: 2022-02-23 Impact factor: 4.456
Authors: Swarup S Swaminathan; Alessandro A Jammal; Helen L Kornmann; Philip P Chen; William J Feuer; Felipe A Medeiros; Steven J Gedde Journal: Ophthalmology Date: 2020-03-04 Impact factor: 14.277
Authors: Amanda K Bicket; Aleksandra Mihailovic; Chengjie Zheng; Michael Saheb Kashaf; Niranjani Nagarajan; Andy S Huang; Sagar Chapagain; Joseph Da; Pradeep Y Ramulu Journal: Am J Ophthalmol Date: 2021-02-21 Impact factor: 5.488