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

Last updated: April 7, 2025
Sponsor: Edinburgh Biosciences Ltd
Overall Status: Completed

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

Treated with Ledinbio device

Clinical Study ID

NCT05396547
EB-CE-01
  • Ages 40-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS IIIgrade 1 to 3 (moderate), as confirmed by the Investigator

  2. Subject aged between 40 and 85 years of age (inclusive) at the time of consent

  3. Best Corrected Visual Acuity (BCVA) of 0.3 LogMAR or worse due to cataract only

  4. Subject whom the medical health history has been reviewed by the Investigator andmedical records do not contraindicate the participation to the study

  5. Subject who is judged suitable for the study after ophthalmic examination carriedout by the Investigator

  6. Be able and willing to follow instructions, including participation in all studyassessments and visits, according to the opinion of the investigator - includingbeing able to sit upright for at least 20 mins (duration of the treatment)

Exclusion

Exclusion Criteria:

  1. Subject unable to give voluntary written informed consent, is unlikely to cooperateor is legally incompetent, including subjects who are institutionalised by court orofficial order, or in a dependency relationship with sponsor, testing centre orinvestigator

  2. Subject who had been clinically diagnosed with any eye diseases which may impactupon the treatment, or the subject's ability to be assessed after treatment

  3. Subjects with intraocular lens (IOL) implant in either eye

  4. Planned replacement of crystalline lens with intraocular lens (IOL) implant withinthe planned study period

  5. Subject with shallow anterior chamber

  6. Subject who have had a fluorescence angiogram or any use of fluorescein within thelast 3 days

  7. Subject presenting eye infection or eye damage in either eye

  8. Any condition which could interfere with the subject's ability to comply with thestudy including participation in all study assessments and visits.

  9. Subject who had undergone a treatment using photodynamic drugs within the last 30days. (Including but not limited to methylene blue, toluidine blue, Visudyne®,Foscan, Photofrin or 5-aminolevulinic acid/ALA)

  10. Subject diagnosed with any other health condition which, in the opinion of theInvestigator, 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

  11. Subject currently receiving treatment in another investigational study or hascompleted another investigational study within the last 30 days

  12. Subject participated in the previous study with the LEDINBIO CE Device (EB-14-LAT)

  13. Females who are pregnant or lactating

  14. Females who are of childbearing potential (menses within the last 12 months) and nottaking adequate contraceptive precautions are excluded from the trial. Females ofchildbearing potential taking acceptable contraceptive precautions may be included.

Study Design

Total Participants: 114
Treatment Group(s): 1
Primary Treatment: Treated with Ledinbio device
Phase:
Study Start date:
June 28, 2022
Estimated Completion Date:
February 02, 2025

Study 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 (blue light treatment beam: Visit 1: 15 minutes, Visits 2 - 9: 20 minutes). 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.

Connect with a study center

  • Lens-L Ltd

    Liepaja, LV-3401
    Latvia

    Site Not Available

  • Dr.Solomatina Acu Centrs

    Riga, LV-1050
    Latvia

    Site Not Available

  • Zielmelkurzeme Regional Hospital

    Ventspils, LV - 3601
    Latvia

    Site Not Available

  • The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of Ophthalmology

    Kaunas,
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santaros Klinikos, Center of Eye Diseases

    Vilnius,
    Lithuania

    Site Not Available

  • Spitalul Clinic de Urgențe Oftalmologice, Depatement of Ophthamology

    Bucharest,
    Romania

    Site Not Available

  • Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila

    Cluj-Napoca, 400371
    Romania

    Site Not Available

  • CF Timisoara Clinical Hospital

    Timisoara, 300173
    Romania

    Site Not Available

  • Clinica Vista, Ophtalmology Department

    Timişoara,
    Romania

    Site Not Available

  • Clinica de Oftalmologie Dr. Berghian

    Timişoara,
    Romania

    Site Not Available

  • Opticlass Ophthalmology Clinic

    Timişoara, 300012
    Romania

    Site Not Available

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