A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive LEDINBIO Proof-Of-Concept Device
Last updated on July 2021Recruitment
- 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