FDA/NEI Pilot validation study of computer administration of vision targeted quality of life instruments


The purpose of this protocol is to compare vision targeted quality of life reported by participants when using web-based questionnaires versus their responses obtained when using standard paper versions of the questionnaires. This comparison will be performed in a population of patients diagnosed with ocular surface disease (OSD) and in age- and gender-matched controls by using a randomized, cross-over study design.  This type of comparative study of patient-reported outcomes has been reported for rheumatology, cardiology, psychiatry, asthma, alcoholism, pain assessment, gastrointestinal disease, diabetes, and allergy populations; however, to our knowledge there have been no reports of such a study from patients with ocular disease.  The study will evaluate the agreement between scores reported via two modes of administration: a web-based version and a paper-and-pencil version.  Components of three validated questionnaires used to evaluate visual function, symptoms, and vision-related quality of life will be included: the initial 5 questions of the Ocular Surface Index © (OSDI), question #15 of the National Eye Institute Visual Functioning Questionnaire – 25 (VFQ-25), and specified domains of the National Eye Institute Refractive Error Quality Of Life Instrument—42 (RQL-42) (clarity of vision, near vision, far vision, glare, symptoms, worry, and satisfaction with correction).


The study will also evaluate whether there are differences in mean overall score by age, gender, order of administration, or disease severity.


Ocular surface disease, which includes dry eye disease secondary to a variety of etiologies, including LASIK, is an ophthalmic condition which places a burden not just on functional vision, but also on overall health related quality of life (HRQoL), with an impact similar to that of moderate angina as measured by utility assessment.  This study will add to the body of knowledge in the field of patient-reported outcome measures (PROs), and will be the first to compare the computerized, web-based and paper-based versions of previously validated questionnaires used to assess QoL in subjects with ocular disease.


There has been an increasing interest in assessing PROs in many fields of medicine, especially in the context of clinical trials where HRQoL is an important component of the overall evaluation of an intervention or treatment.  As the use of computers increases and accessibility to the internet broadens, there is a tremendous potential in harnessing this technology in the future as a cost-effective, efficient way to gather clinical data on PROs for future ophthalmic clinical trials and studies.