Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Cataract
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single arm interventional studyMasking: None (Open Label)Masking Description: UnmaskedPrimary Purpose: Treatment

Participation Requirements

Age
Between 55 years and 85 years
Gender
Both males and females

Description

Single arm, single site proof-of-concept trial to evaluate the safety and efficacy of the LEDINBIO PoC Device, with 8 x 15-minute twice-weekly treatments and 3 month safety follow-up, in the treatment of cataract. Only one of the subject's eyes will be treated during the study. In addition, spectral...

Single arm, single site proof-of-concept trial to evaluate the safety and efficacy of the LEDINBIO PoC Device, with 8 x 15-minute twice-weekly treatments and 3 month safety follow-up, in the treatment of cataract. Only one of the subject's eyes will be treated during the study. In addition, spectral data (fluorescent emission) will be collected using the device to monitor the progress of the treatment, and to determine the suitability of these measurements for future clinical diagnoses

Tracking Information

NCT #
NCT04569318
Collaborators
Onorach Clinical
Investigators
Study Chair: Chief Executive Edinburgh Biosciences Ltd