Age-related CataractNCT05396547
Study On The Performance And Safety Of The REVISYON SDS 100 Device On Visual Acuity In Subjects With Cataract
A study testing Treated with REVISYON SDS 100 Device in people with Age-related Cataract, run by Edinburgh Biosciences Ltd at 11 sites in 3 countries.
Trial summary
Single arm, unmasked study to evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- Treated with REVISYON SDS 100 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 28 Jun 2022to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator
- Subject aged between 40 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)
Who cannot join
- 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
Show all 14Show fewer
- 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 REVISYON 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.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Romania6 sites
Spitalul Clinic de Urgențe Oftalmologice, Depatement of Ophthamology
Bucharest
Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila
Cluj-Napoca, 400371
Opticlass Ophthalmology Clinic
Timișoara, 300012
CF Timisoara Clinical Hospital
Timișoara, 300173
Clinica de Oftalmologie Dr. Berghian
Timișoara
Clinica Vista, Ophtalmology Department
Timișoara
Latvia3 sites
Lens-L Ltd
Liepāja, LV-3401
Dr.Solomatina Acu Centrs
Riga, LV-1050
Zielmelkurzeme Regional Hospital
Ventspils, LV - 3601
Lithuania2 sites
The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of Ophthalmology
Kaunas
Vilnius University Hospital Santaros Klinikos, Center of Eye Diseases
Vilnius
About this study
Single arm, unmasked study to evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract.
Read the detailed description
This single arm, unmasked study will evaluate the performance and safety of the REVISYON SDS 100 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 REVISYON SDS 100 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 REVISYON SDS 100 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 REVISYON SDS 100 Device to monitor the progress of the treatment, and to determine the suitability of these measurements for future clinical diagnoses.
- Conditions
- Age-related Cataract
- Being tested
- Treated with REVISYON SDS 100 Device
- Keywords
- non-invasive cataract treatment, N-LOCS III grade 1 to 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treated with REVISYON SDS 100 DeviceDevice
Treated with REVISYON SDS 100 Device
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Treatment with REVISYON SDS 100 Device Receives: Device: Treated with REVISYON SDS 100 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity
Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale.
Measured: 4 weeks
Secondary outcomes (2)
Change in Cataract Severity
Change in Cataract Severity, assessed using LOCS III
Measured: 4 weeks
Subjective satisfaction using Visual Function Index
Subjective satisfaction, assessed using Visual Function Index (VF-14). The total result per subject is divided by the maximum possible result, excluding questions marked as "N/A," to determine the differences between the VF-14 result at Visit 1 and the VF-14 result at Visit 10. Higher scores mean a better outcome
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start28 Jun 2022
- Primary completion4 Jan 2025
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm interventional study
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edinburgh Biosciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Responsible party
- Sponsor
- Investigators
- Trevor Shields, Study director, Edinburgh Biosciences Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396547
- Sponsor's protocol ID
- EB-CE-01
- Status last verified
- Nov 2025
- First submitted
- 25 May 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study On The Performance And Safety Of The REVISYON SDS 100 Device On Visual Acuity In Subjects With Cataract
- ClinicalTrials.gov ID
- NCT05396547
- Acronym / sponsor ID
- EB-CE-01
- Conditions
- Age-related Cataract
- Keywords
- non-invasive cataract treatment, N-LOCS III grade 1 to 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Edinburgh Biosciences LtdIndustry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm, unmasked study to evaluate the performance and safety of the REVISYON SDS 100 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 REVISYON SDS 100 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 REVISYON SDS 100 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 REVISYON SDS 100 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 REVISYON SDS 100 Device to monitor the progress of the treatment, and to determine the suitability of these measurements for future clinical diagnoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm interventional study
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Device: Treated with REVISYON SDS 100 DeviceTreatment with REVISYON SDS 100 Device |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator
- Subject aged between 40 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treated with REVISYON SDS 100 DeviceTreated with REVISYON SDS 100 Device | Device | Treated |
Primary outcome
Change in Visual Acuity
Time frame: 4 weeks
Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale.
2 secondary outcomes
Change in Cataract Severity
Time frame: 4 weeks
Subjective satisfaction using Visual Function Index
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trevor Shields study director
Edinburgh Biosciences Ltd
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treated with REVISYON SDS 100 Device in people with Age-related Cataract, run by Edinburgh Biosciences Ltd at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Romania, Latvia, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Acuity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.