Stopped: Several reasons: Financing ended before all study assessments were performed, covid-19 delayed design, production and shipment of IMD, experience gained during the study made it clear that lens design should be changed
Data from 15 healthy subjects will be recorded in two testing sessions spread on two days, using three lens designs (A, B and C). Before the measuring days, each subject will undergo an extra fitting session of a large-diameter scleral contact lens on the dominant eye, assessed by an experienced practitioner. The fitting data will be used to custom-make the three lens designs for each subject, thus ensuring their comfort and safety during the days of the experiments. During the experiment days baseline measurements will be obtained before and after pupil dilation and contact lens wear. During the first testing session data from the lens design A (reference lens without artificial iris) will be recorded. During the second testing session data from the lens designs B and C (lenses with artificial iris with different transmittances) will be recorded. In each testing session, contrast sensitivity and visual acuity will be evaluated and non-invasive imaging measurements will be undertaken (optical coherence tomography and slit lamp). A specific questionnaire will be given to the subject to assess comfort, light sensitivity, the horizontal visual angle and overall experience of the scleral lens and in combination with a pair of sunglasses category 3-4.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Visual acuity assessment and comparison between Designs A, B and C by means of logMAR or equivalent value
Timeframe: 5 months from fitting session
Contrast sensitivity assessment and comparison between Designs A, B and C by means of threshold percentage or equivalent value
Timeframe: 5 months from fitting session