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The performance of the refractive status and vision profile survey in a contact lens clinical trial
J J Nichols1, G L Mitchell, K Zadnik
1The Ohio State University, College of Optometry, Columbus, Ohio 43218-2342, USA.
Objective:
To evaluate the Refractive Status and Vision Profile (RSVP) questionnaire 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 participants 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) after wearing disposable extended wear contact lenses. One-sample t tests were 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 subjects required in future studies to detect differences in RSVP subscale scores.
Main Outcome Measures:
Eight subscale scores (concern, driving, expectations, 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 score were significantly lower than those previously reported. No differences were found in the following subscales after contact lens treatment: concern, expectations, physical and social functioning, driving, optical problems, problems with corrective lenses, or the overall RSVP score. Significant differences were found on the symptoms (P = 0.03) and glare (P = 0.05) subscales; post hoc testing revealed that the significant differences in these scores occurred between baseline and daily disposable lens wear and not between treatment modalities (daily disposable and disposable extended wear). A sample size of 420 would be required to find clinically relevant significant differences (25%) for all subscales in a similar one-sample clinical trial. A more restrictive difference (10%) would require more than 1100 subjects for four of the nine subscales.
Conclusions:
The RSVP questionnaire may not be the appropriate quality-of-life instrument for use in a contact lens clinical trial. The instrument seems to lack sensitivity and discriminative validity in evaluating contact lens treatments.
