Purpose: The Children's Visual Function Questionnaire (CVFQ) is a vision-specific quality-of-life instrument designed for use with children up to 7 years of age. The goal of this study was to assess the construct validity of CVFQ subscales by examining their sensitivity to four research questions commonly posed in ophthalmic clinical trials.
Methods: CVFQ Competence, Personality, Family Impact, and Treatment Difficulty subscale scores were compared for groups of pediatric patients with unilateral versus bilateral disease (35 bilateral and 38 unilateral cataract), different severity of visual impairment (61 retinopathy of prematurity [ROP] grouped by acuity), difficulty of treatment regimen (22 optical, 44 surgery, 38 surgery with optical, and 35 surgery with optical and occlusion), and alternative treatments for the same condition (24 intraocular lenses, 37 aphakic contact lenses).
Results: Patients treated for bilateral cataracts had significantly worse Competence subscale scores than patients treated for unilateral cataract, and patients with bilateral severe ROP (visual acuity 20/200 or poorer in both eyes) had significantly worse Competence subscale scores than other patients with ROP. Treatment Difficulty subscale scores were worse for patients with unilateral cataracts than for those with bilateral cataracts, worse for patients treated with occlusion therapy than for those treated with surgery or optical correction, and worse for those treated with an aphakic contact lens than for those treated with an intraocular lens. Family Impact subscale scores were worse for patients with unilateral cataracts than for those with bilateral cataracts, worse for patients treated with surgery than for those treated with optical correction, and worse for those with severe bilateral ROP than for any other patients with ROP.
Conclusions: The CVFQ subscales quantified meaningful differences among pediatric patient groups who were chosen to address key research questions commonly posed in ophthalmic clinical trials.