Cataract in Old Age Clinical Trial
Official title:
Study On The Performance And Safety Of The LEDINBIO CE Device On Visual Acuity In Subjects With Cataract
Single arm, unmasked study to evaluate the performance and safety of the LEDINBIO CE Device for the non-invasive treatment of vision loss in age-related cataract.
This single arm, unmasked study will evaluate the performance and safety of the LEDINBIO CE Device for the non-invasive treatment of vision loss in age-related cataract. Only one of the subject's eyes will be treated with the LEDINBIO CE Device during the study (415 nm treatment beam: Visit 1: 15 minutes at 20 mW, Visits 2 - 9: 20 minutes at 24 mW). The Treatment period will last 19 days (+ 1 day), starting with the day of first treatment (Visit 1, day 1). During this period, subjects will be treated with the LEDINBIO investigational device three-times a week for 3 weeks (Visit 1 to Visit 9) up to a maximum of 20 days (or 2.9 weeks). The Treatment period will be followed by 84 days (± 10 days) of follow up, up to a maximum of 94 days (or 13.4 weeks). The subject's eyes will be examined throughout the study to allow safety and performance to be monitored. The safety examinations includes standard ophthalmological tests. Clinical assessments in the study will use traditional ophthalmic methods including LogMAR best corrected visual acuity (BCVA) for distance, and grading of cataracts using LOCS III. In addition, spectral data (fluorescent emission) will be collected using the LEDINBIO CE Device to monitor the progress of the treatment, and to determine the suitability of these measurements for future clinical diagnoses. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT04047485 -
Evaluation of the Effect of Cataract Surgery on Cognitive Function in Very Elderly Patients
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