Quality of Life in the Tube Versus Trabeculectomy Study.
OBJECTIVE
To report the vision-specific quality-of-life (QoL) outcomes in the Tube Versus Trabeculectomy (TVT) Study.


METHODS
Multicenter randomized clinical trial.


METHODS
Setting: Seventeen clinical centers.


METHODS
Patients 18-85 years of age with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery.


METHODS
Tube shunt (350-mm2Baerveldt glaucoma implant) or trabeculectomy with MMC.


METHODS
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.
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.
Aachal
A
Kotecha
Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, Florida.
William J
WJ
Feuer
NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.
Keith
K
Barton
Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, Florida.
Steven J
SJ
Gedde
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D005260:Female; D005500:Follow-Up Studies; D005901:Glaucoma / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D020327:Glaucoma Drainage Implants; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012086:Reoperation; D014130:Trabeculectomy / Q000379:methods*; D016896:Treatment Outcome; D014792:Visual Acuity; D055815:Young Adult