The performance of the refractive status and vision profile survey in a contact lens clinical trial

Objective: To evaluate the Refractive Status and Vision Profile (RSVP) ques tionnaire in a contact lens clinical trial and to assess the feasibility of its use in future trials. Design: Randomized, crossover clinical trial and survey. Participants: The RSVP was administered to 50 contact lens-wearing particip ants recruited from a large contact lens clinic. Methods: RSVP scores were calculated for subjects at three outcome visits: (1) baseline, (2) after wearing daily disposable contact lenses, and (3) af ter wearing disposable extended wear contact lenses. One-sample t tests wer e used to compare baseline survey scores with those previously reported for the instrument. The relation of survey scores within and between subjects was assessed with repeated measures analysis of variance. Statistical power and sample size calculations were performed to determine the number of sub jects required in future studies to detect differences in RSVP subscale sco res. Main Outcome Measures: Eight subscale scores (concern, driving, expectation s, glare, optical problems, physical and social functioning, problems with corrective lenses, and symptoms) and the overall RSVP score were calculated on the basis of guidelines reported for scoring of the instrument. Results: Five of eight mean subscale scores (concern, expectations, driving , optical problems, and problems with corrective lenses) and the overall sc ore were significantly lower than those previously reported. No differences were found in the following subscales after contact lens treatment: concer n, expectations, physical and social functioning, driving, optical problems , problems with corrective lenses, or the overall RSVP score. Significant d ifferences were found on the symptoms (P = 0.03) and glare (P = 0.05) subsc ales; post hoc testing revealed that the significant differences in these s cores occurred between baseline and daily disposable lens wear and not betw een treatment modalities (daily disposable and disposable extended wear). A sample size of 420 would be required to find clinically relevant significa nt differences (25%) for all subscales in a similar one-sample clinical tri al. A more restrictive difference (10%) would require more than 1100 subjec ts for four of the nine subscales. Conclusions: The RSVP questionnaire may not be the appropriate quality-of-l ife instrument for use in a contact lens clinical trial. The instrument see ms to lack sensitivity and discriminative validity in evaluating contact le ns treatments. Ophthalmology 2001;108:1160-1166 (C) 2001 by the American Ac ademy of Ophthalmology.