CataractNCT04569318
A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device
A study testing Treatment Beam in people with Cataract, run by Edinburgh Biosciences Ltd at 1 site in Latvia.
Trial summary
Single arm proof-of-concept trial to evaluate the safety and efficacy of the REVISYON PoC Device in the treatment of cataract. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Treatment Beam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteLatvia
- Study dates
- 19 Oct 2020to 9 Sep 2021
- 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 55 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 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)
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
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Single arm proof-of-concept trial to evaluate the safety and efficacy of the REVISYON PoC Device in the treatment of cataract.
Read the detailed description
Single arm, single site proof-of-concept trial to evaluate the safety and efficacy of the REVISYON 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
- Conditions
- Cataract
- Being tested
- Treatment Beam
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment BeamDevice
One of the subject's eyes will be treated with the treatment beam (20mW) up to 8 times for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Treatment with treatment beam. Receives: Device: Treatment Beam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 weeks
Efficacy: Cataract Grade
Assessment of efficacy, defined as treating cataract assessed using Lens Opacities Classification System (LOCS) III. Higher scores mean a worse outcome.
Measured: 5 weeks
Secondary outcomes (4)
Change in cataract severity
Assessed using Objective Scatter Index (OSI) using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Measured: 5 weeks
Change in visual acuity
Assessed using LogMAR (Logarithm of the Minimum Angle of Resolution) scale. Higher scores mean a worse outcome.
Measured: 5 weeks
Change in light scatter
Assessed using Visiometrics HD Analyser. Higher scores mean a worse outcome.
Measured: 5 weeks
Change in functional impairment due to cataract
Assessed using VF-14 (Visual Function Index) questionnaire data. Higher scores mean a better outcome.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start19 Oct 2020
- Primary completion19 Aug 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edinburgh Biosciences Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Onorach Clinical
- Responsible party
- Sponsor
- Investigators
- Chief Executive, Study chair, Edinburgh Biosciences Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569318
- Sponsor's protocol ID
- EB-14-LAT
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2020
- 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
- A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device
- ClinicalTrials.gov ID
- NCT04569318
- Acronym / sponsor ID
- EB-14-LAT
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Edinburgh Biosciences LtdIndustry (pharma, biotech, devices)
- Collaborators
- Onorach Clinical
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 29 Sep 2020 (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 proof-of-concept trial to evaluate the safety and efficacy of the REVISYON 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 REVISYON 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
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 |
|---|---|---|
| Treatment Arm | Experimental | Device: Treatment BeamTreatment with treatment beam. |
Who may qualify
- Ages
- 55 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 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
Key exclusion criteria (13 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
- 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
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 |
|---|---|---|
| Treatment BeamOne of the subject's eyes will be treated with the treatment beam (20mW) up to 8 times for 15 minutes. | Device | Treatment Arm |
Primary outcome
Safety: assessed by changes in the Local Ocular Tolerability (LOT) Visual Analogue Scale (VAS)
Time frame: 20 weeks
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
Time frame: 5 weeks
Assessment of efficacy, defined as treating cataract assessed using Lens Opacities Classification System (LOCS) III. Higher scores mean a worse outcome.
4 secondary outcomes
Change in cataract severity
Time frame: 5 weeks
Change in visual acuity
Time frame: 5 weeks
Change in light scatter
Time frame: 5 weeks
Change in functional impairment due to cataract
Time frame: 5 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.
Chief Executive study chair
Edinburgh Biosciences Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Beam in people with Cataract, run by Edinburgh Biosciences Ltd at 1 site in Latvia.
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 13 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 1 site in Latvia. 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?
Safety: assessed by changes in the Local Ocular Tolerability (LOT) Visual Analogue Scale (VAS) (time frame: 20 weeks). The study lists 2 primary outcomes in all. 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.