A one-year prospective study on scleral lens wear success

To report the success rate of scleral lens wear and the lens handling learning curve from the wearers perspective.

Ninety-five participants were consecutively screened for enrollment in a prospective study. Participants were divided into two groups: ICGroup (71 participants with irregular corneas) and RCGroup (24 participants with regular corneas). Participants attended several visits: Baseline, Lens Dispense Visit (LDV), 1-month, 3-month, 6-month and 12-month follow-ups. The number and causes of scleral lens discontinuation and the time to correctly apply the lens for the first time at the LDV were evaluated. During follow-ups, participants answered a questionnaire regarding scleral lens wear (mean number of hours/day and days/week of lens wear, methods used for handling, number of attempts to correctly apply and remove the lenses).

Sixty-nine participants (73 %) successfully completed the 12-month period. Twenty-six participants (27 %) discontinued scleral lens wear. None of the discontinuations were due to adverse events. The success rate (number of participants that wore the lenses for the 12 months) was 77 % in ICGroup and 58 % in RCGroup. The main reasons for scleral lens discontinuation were handling issues (35 %) and discomfort (19 %). 36 % of participants required <15 min to correctly apply the lens at the LDV, however 13 % required >60 min (participants that wore spectacles, soft lenses or had no correction method at Baseline). The mean wearing time (hours/day and days/week) increased significantly from 1-month to 12-month appointments: from 9.8-11.1 h and 5.1-5.6 days in new scleral lens wearers, while the number of attempts to correctly apply and remove the lenses decreased significantly.

The success rate was 73 % during this prospective 12-month follow-up study. The main reasons for drop-out were handling issues and discomfort. Participants who continued scleral lens demonstrated increased handling skills.