Study On The Performance And Safety Of The LEDINBIO CE Device On Visual Acuity In Subjects With Cataract

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Study On The Performance And Safety Of The LEDINBIO CE Device On Visual Acuity In Subjects With Cataract

Conditions
-----------------
Cataract in Old Age

Intervention / Treatment
-----------------
* Device: Treated with Ledinbio device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator Subject aged between 55 and 85 years of age (inclusive) at the time of consent Best Corrected Visual Acuity (BCVA) of 0.3 LogMAR or worse due to cataract only Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study Subject who is judged suitable for the study after ophthalmic examination carried out by the Investigator Be able and willing to follow instructions, including participation in all study assessments and visits, according to the opinion of the investigator - including being able to sit upright for at least 20 mins (duration of the treatment) Exclusion Criteria: Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalised by court or official order, or in a dependency relationship with sponsor, testing centre or investigator Subject who had been clinically diagnosed with any eye diseases which may impact upon the treatment, or the subject's ability to be assessed after treatment Subjects with intraocular lens (IOL) implant in either eye Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period Subject with shallow anterior chamber Subject who have had a fluorescence angiogram or any use of fluorescein within the last 3 days Subject presenting eye infection or eye damage in either eye Any condition which could interfere with the subject's ability to comply with the study including participation in all study assessments and visits. Subject who had undergone a treatment using photodynamic drugs within the last 30 days. (Including but not limited to methylene blue, toluidine blue, Visudyne®, Foscan, Photofrin or 5-aminolevulinic acid/ALA) Subject diagnosed with any other health condition which, in the opinion of the Investigator, would pose a safety risk to the subject by participating in the study, or may interfere with or jeopardise the study evaluation, procedures or completion Subject currently receiving treatment in another investigational study or has completed another investigational study within the last 30 days Subject participated in the previous study with the LEDINBIO CE Device (EB-14-LAT) Females who are pregnant or lactating Females who are of childbearing potential (menses within the last 12 months) and not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable contraceptive precautions may be included.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated<br>Treatment with Ledinbio device | Device: Treated with Ledinbio device<br>* Treated with Ledinbio device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Acuity | Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cataract Severity | Change in Cataract Severity, assessed using LOCS III | 4 weeks | 
| Change in Cataract Severity | Change in Cataract Severity, assessed using Visual Function Index (VF-14) | 4 weeks |