The committee agreed that further research was needed because there is currently no clinical- or cost-effectiveness evidence evaluating the use of Holoclar in both eyes in bilateral patients. The committee was aware of the ongoing HOLOCORE trial which is recruiting both unilateral and bilateral patients, but only evaluates the success of a second transplant in 1 eye rather than transplant success in both eyes.
The committee recommended that further research should be designed to generate robust evidence of the clinical- and cost-effectiveness of Holoclar for treating both eyes in people with bilateral limbal stem cell deficiency after eye burns if they do not have enough tissue for a conjunctival limbal autograft. The study should recruit people with bilateral disease and evaluate the effectiveness of treatment in both eyes. Outcomes should include transplant success and assessments of health-related quality of life using a generic preference-based measure.