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

Primary Purpose

Cataract in Old Age

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Treated with Ledinbio device
Sponsored by
Edinburgh Biosciences Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract in Old Age

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator
  2. Subject aged between 55 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 and medical records do not contraindicate the participation to the study
  5. Subject who is judged suitable for the study after ophthalmic examination carried out by the Investigator
  6. 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:

  1. 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
  2. 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
  3. Subjects with intraocular lens (IOL) implant in either eye
  4. Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period
  5. Subject with shallow anterior chamber
  6. Subject who have had a fluorescence angiogram or any use of fluorescein within the last 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 the study including participation in all study assessments and visits.
  9. 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)
  10. 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
  11. Subject currently receiving treatment in another investigational study or has completed 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 not taking adequate contraceptive precautions are excluded from the trial. Females of childbearing potential taking acceptable contraceptive precautions may be included.

Sites / Locations

  • Lens-L LtdRecruiting
  • Dr.Solomatina Acu CentrsRecruiting
  • Zielmelkurzeme Regional HospitalRecruiting
  • The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of OphthalmologyRecruiting
  • Vilnius University Hospital Santaros Klinikos, Center of Eye DiseasesRecruiting
  • Spitalul Clinic de Urgențe Oftalmologice, Depatement of OphthamologyRecruiting
  • Clinica de Oftalmologie Dr. BerghianRecruiting
  • Clinica Vista, Ophtalmology DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated

Arm Description

Treatment with Ledinbio device

Outcomes

Primary Outcome Measures

Change in Visual Acuity
Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale.

Secondary Outcome Measures

Change in Cataract Severity
Change in Cataract Severity, assessed using LOCS III
Change in Cataract Severity
Change in Cataract Severity, assessed using Visual Function Index (VF-14)

Full Information

First Posted
May 25, 2022
Last Updated
May 23, 2023
Sponsor
Edinburgh Biosciences Ltd
Collaborators
Onorach Clinical
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1. Study Identification

Unique Protocol Identification Number
NCT05396547
Brief Title
Study On The Performance And Safety Of The LEDINBIO CE Device On Visual Acuity In Subjects With Cataract
Official Title
Study On The Performance And Safety Of The LEDINBIO CE Device On Visual Acuity In Subjects With Cataract
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edinburgh Biosciences Ltd
Collaborators
Onorach Clinical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract in Old Age

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treated
Arm Type
Experimental
Arm Description
Treatment with Ledinbio device
Intervention Type
Device
Intervention Name(s)
Treated with Ledinbio device
Intervention Description
Treated with Ledinbio device
Primary Outcome Measure Information:
Title
Change in Visual Acuity
Description
Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Cataract Severity
Description
Change in Cataract Severity, assessed using LOCS III
Time Frame
4 weeks
Title
Change in Cataract Severity
Description
Change in Cataract Severity, assessed using Visual Function Index (VF-14)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
K Beaney, PhD
Phone
+441382 561048
Email
info@onorach.com
First Name & Middle Initial & Last Name or Official Title & Degree
T Shields
Phone
+441506 429274
Email
trevor@edinbio.com
Facility Information:
Facility Name
Lens-L Ltd
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora Kronberga
Phone
+29106253
First Name & Middle Initial & Last Name & Degree
Nora Kronberga, Dr
First Name & Middle Initial & Last Name & Degree
Ieva Kuzma, Dr
First Name & Middle Initial & Last Name & Degree
Voldemars Dubults, Dr
Facility Name
Dr.Solomatina Acu Centrs
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igors Solomatins, Prof
Phone
+371 67217317
Email
acucentrs@acucentrs.lv
First Name & Middle Initial & Last Name & Degree
Igors Solomatins, Prof
First Name & Middle Initial & Last Name & Degree
Maksims Solomatins, MD
First Name & Middle Initial & Last Name & Degree
Andrei Solomatins, MD
Facility Name
Zielmelkurzeme Regional Hospital
City
Ventspils
ZIP/Postal Code
LV - 3601
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaspars Ozols, Dr
Phone
+37163624665
First Name & Middle Initial & Last Name & Degree
Kaspars Ozols, Dr
Facility Name
The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of Ophthalmology
City
Kaunas
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reda Žemaitienė, Professor
First Name & Middle Initial & Last Name & Degree
Agnė Markevičiūtė, Dr., MD
First Name & Middle Initial & Last Name & Degree
Indrė Markevičiūtė, Dr., MD
First Name & Middle Initial & Last Name & Degree
Agnė Sidaraitė, Dr., MD
Facility Name
Vilnius University Hospital Santaros Klinikos, Center of Eye Diseases
City
Vilnius
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rimvydas Stanislovas Ašoklis, Ass Prof
First Name & Middle Initial & Last Name & Degree
Rimvydas Stanislovas Ašoklis, Ass Prof
First Name & Middle Initial & Last Name & Degree
Ramūnas Riauka, Dr., MD
Facility Name
Spitalul Clinic de Urgențe Oftalmologice, Depatement of Ophthamology
City
Bucharest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentin Dinu, MD
Phone
+40 724 087 953
Email
valentin.dinu@umfcd.ro
First Name & Middle Initial & Last Name & Degree
Valentin Dinu, MD
Facility Name
Clinica de Oftalmologie Dr. Berghian
City
Timişoara
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adina Berghian, MD
Phone
+40 722 765 168
Email
adinab24@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Adina Berghian, MD
Facility Name
Clinica Vista, Ophtalmology Department
City
Timişoara
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Otilia Brinzan, MD
Phone
+40 724 087 953
Email
otiliabrinzan@yahoo.com
First Name & Middle Initial & Last Name & Degree
Otilia Brinzan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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