A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive LEDINBIO Proof-Of-Concept Device
Primary Purpose
Cataract
Status
Terminated
Phase
Not Applicable
Locations
Latvia
Study Type
Interventional
Intervention
Treatment Beam
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
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 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
- 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
- Subject routinely using contact lenses
- Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period
- 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
- 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.
Sites / Locations
- Dr.Solomatina Acu Centrs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Treatment with treatment beam.
Outcomes
Primary Outcome Measures
Safety: assessed by changes in the Local Ocular Tolerability (LOT) Visual Analogue Scale (VAS)
Assessment of safety defined as changes in the LOT VAS. A self-administered 7-item (foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia) 100 mm VAS on which 0 means no symptoms and 100 means the worst possible discomfort. VAS Ocular Tolerability Overall score is the mean of all VAS Ocular Tolerability symptom scores per visit per eye
Efficacy: Cataract Grade
Assessment of efficacy, defined as treating cataract assessed using Lens Opacities Classification System (LOCS) III. Higher scores mean a worse outcome.
Secondary Outcome Measures
Change in cataract severity
Assessed using Objective Scatter Index (OSI) using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Change in visual acuity
Assessed using LogMAR (Logarithm of the Minimum Angle of Resolution) scale. Higher scores mean a worse outcome.
Change in light scatter
Assessed using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Change in functional impairment due to cataract
Assessed using VF-14 (Visual Function Index) questionnaire data. Higher scores mean a better outcome.
Full Information
NCT ID
NCT04569318
First Posted
September 17, 2020
Last Updated
September 27, 2021
Sponsor
Edinburgh Biosciences Ltd
Collaborators
Onorach Clinical
1. Study Identification
Unique Protocol Identification Number
NCT04569318
Brief Title
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive LEDINBIO Proof-Of-Concept Device
Official Title
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive LEDINBIO Proof-Of-Concept Device
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Study objectives met
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
August 19, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)
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 proof-of-concept trial to evaluate the safety and efficacy of the LEDINBIO PoC Device in the treatment of cataract.
Detailed 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
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)
Masking Description
Unmasked
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Treatment with treatment beam.
Intervention Type
Device
Intervention Name(s)
Treatment Beam
Intervention Description
One of the subject's eyes will be treated with the 415 nm treatment beam (20mW) up to 8 times for 15 minutes.
Primary Outcome Measure Information:
Title
Safety: assessed by changes in the Local Ocular Tolerability (LOT) Visual Analogue Scale (VAS)
Description
Assessment of safety defined as changes in the LOT VAS. A self-administered 7-item (foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia) 100 mm VAS on which 0 means no symptoms and 100 means the worst possible discomfort. VAS Ocular Tolerability Overall score is the mean of all VAS Ocular Tolerability symptom scores per visit per eye
Time Frame
20 weeks
Title
Efficacy: Cataract Grade
Description
Assessment of efficacy, defined as treating cataract assessed using Lens Opacities Classification System (LOCS) III. Higher scores mean a worse outcome.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Change in cataract severity
Description
Assessed using Objective Scatter Index (OSI) using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Time Frame
5 weeks
Title
Change in visual acuity
Description
Assessed using LogMAR (Logarithm of the Minimum Angle of Resolution) scale. Higher scores mean a worse outcome.
Time Frame
5 weeks
Title
Change in light scatter
Description
Assessed using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Time Frame
5 weeks
Title
Change in functional impairment due to cataract
Description
Assessed using VF-14 (Visual Function Index) questionnaire data. Higher scores mean a better outcome.
Time Frame
5 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 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
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
Subject routinely using contact lenses
Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Executive
Organizational Affiliation
Edinburgh Biosciences Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Dr.Solomatina Acu Centrs
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive LEDINBIO Proof-Of-Concept Device
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