OBJECTIVES:

Presbyopia is the age-related loss in near distance focusing ability. The aim of this study was to identify and review patient-reported outcome (PRO) assessments used in clinical trials and quality of life (QoL) studies conducted in presbyopic patients.

METHODS:

Literature searches were performed in Medline and Embase up until October 2017. Specific search terms were used to identify studies in presbyopia that included a PRO instrument or reported on patient QoL. All clinical trials with PRO endpoints in presbyopia were identified on clinicaltrials.gov. Further searches were conducted to retrieve articles documenting the development and psychometric evaluation of PROs.

RESULTS:

A total of 746 abstracts were identified and 120 were selected for full-text review. Articles reporting on the QoL of patients with presbyopia highlighted the impact of the condition on patients’ daily lives. 21 clinical trials employed PROs to support a primary or secondary endpoint. In total, 13 PROs were identified; a further 23 publications pertaining to development and validation of these tools were retrieved. Most PROs were developed prior to release of FDA 2009 PRO guidance and therefore did not conform to regulatory standards. The Near Activity Visual Questionnaire (NAVQ) was identified as the most appropriate for assessing near vision functioning in presbyopia. While the NAVQ was developed in line with the FDA guidance, its validity has not been confirmed specifically in a presbyopia population as it was developed for use in pseudophakic patients. Furthermore, the items do not reflect changes in technology which have occurred since the questionnaire was developed in 2008 (e.g. the increase in smartphone use).

CONCLUSIONS:

The NAVQ has the potential to support trial endpoints related to changes in near-vision functioning associated with presbyopia. Further research is ongoing to confirm its content validity and psychometric validity in this specific population.