Age-related CataractEB-CE-02NCT07246915
Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)
An observational study of Age-related Cataract and Vision Loss, run by Edinburgh Biosciences Ltd at 6 sites in Romania.
Trial summary
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Age-related Cataract, Vision Loss, Cataract
- How many people
- 47 participants
- Where
- 6 sitesRomania
- Study dates
- 8 Nov 2025to 17 Feb 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult subjects, affected by vision loss due to early-stage cataract who had been assessed for BCVA and LOCS III nuclear grade and underwent treatment during the EB-CE-01 clinical investigation
Who may be able to join
- Subjects who have initiated the EB-CE-01 study treatment phase in Romania
- Availability of complete retrospective data from the EB-CE-01 study- specifically from visit 12 assessment- including binocular BCVA, binocular LOCS III assessments, binocular slit-lamp assessment, and baseline assignment of the study eye.
- Be able and willing to follow instructions
- Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study. Note: Subjects who underwent cataract surgery in either eye will be allowed to participate
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 involved in other clinical investigation that may compromise the results of the study.
- Subjects developing mental illnesses that can influence their participation in the study (cognitive impairment, psychiatric condition, or neurological disorder).
- Any health condition which could interfere with the subject's ability to comply with the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Romania6 sites
Institutul Clinic de Urgențe Oftalmologice Prof. Dr. Mircea Olteanu
Bucharest
Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila
Cluj-Napoca
Dr. Berghian Ophthalmology Clinic
Timișoara
Opticlass Clinic
Timișoara
Romania Clinica Vista, Ophtalmology Department
Timișoara
Spitalul Clinic CF Timisoara, Ophthalmology Department
Timișoara
About this study
Official title: A Non-interventional, Extension Study on the Long-term Maintenance of Safety and Performance of the REVISYON SDS 100 Medical Device in Subjects With Mild-to-moderate Cataract
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
Read the detailed description
This study is an ancillary study to the EB-CE-01 clinical investigation. No treatment or any study-specific intervention is foreseen for the study subcohort. This study is designed to evaluate the maintenance of safety and efficacy an average 20 months following the end of treatment of mild-to-moderate senile cataract with the medical device in the EB-CE-01 clinical investigation in the Romanian subcohort of subjects. Due to the long enrolment gap and different treatment intervals, the tracking of subjects provided a significant difference in the intervals since treatment completion among subjects.
Therefore, the study approach involves a single additional visit for subjects who initiated treatment, during which supplementary data will be collected from standard-of-care ophthalmological assessments.
In the initial EB-CE-01 study, treatment with the non-invasive medical device REVISYON SDS 100 was administered between April 2023 and December 2024 to 92 patients, all of whom were included in both the Full Analysis Set and the Safety Set. Best corrected visual acuity (BCVA) was assessed at 7 (±1) days, 28 (±4) days, and 84 (±10) days following the final treatment session (known as Visit 9). Treatment efficacy was evaluated at 7 (±1) days only, corresponding to one-week post-treatment.
In this extension study, prospective data will be collected to assess the incidence of any safety events and to evaluate the maintenance of best-corrected visual acuity (BCVA), cataract severity grade, and visual functioning at an additional follow-up visit. The following timepoints from the parent study will be used as reference: EB-CE-01 V0 (pre-treatment), EB-CE-01 V1-V9 (treatment visits), and EB-CE-01 V12 (last efficacy visit), which will serve as the baseline for the current extension study.
The main objective of the study is capturing any new clinically significant findings that meet the definition of an AE in accordance with EU MDR 2017/745 and ISO 14155:2020, as to generate robust safety findings in the pre-market stage.
As secondary objectives, the study will assess the mean change in best-corrected visual acuity (BCVA), the preservation of cataract severity grade, and the subjective evaluation of visual function using The Visual Function Index-14 (VF-14) relative to the last post-treatment assessment, defined at Visit 12 of the EB-CE-01 clinical investigation.
Study participants will be required to provide additional answers related to the visual functioning (VF-14 questionnaire), which will be administered in Romanian using linguistically validated versions. VF-14 questionnaire is a validated, brief questionnaire, including self-reported measures, designed to be completed within a few minutes, and is therefore not expected to constitute a burden or interfere with routine clinical care.
- Conditions
- Age-related Cataract, Vision Loss, Cataract, Mild Cataract, Moderate Cataract
- Keywords
- REVISYON SDS 100, Visual acuity, EB-CE-02, EB-CE-01, Long-term safety, Non-interventional, Extension study, Cataract, Vision loss, LEDINBIO CE Device, Age-related Cataract
- Medical subject headings
- Vision Disorders, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | The study population will consist of adult subjects with vision loss due to mild or moderate cataract, who were previously treated with the medical device in the EB-CE-01 study (one eye only, recorded as the study eye). The exclusion criteria are intended to protect subject safety and to ensure the integrity and validity of the clinical investigation by excluding subjects for whom participation may present undue risk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A summary of adverse events
A summary of adverse events collected over an average of 20 months following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation.
The types of adverse events to be collected (AEs, SADEs, USADEs, AESIs, and SAEs) will be classified by type, severity, outcome, seriousness and causality).
Measured: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
Secondary outcomes (3)
The mean change from Baseline post-treatment in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale
Change in LogMAR = LogMAR (extended visit) - LogMAR (Visit 12, EB-CE-01 study)
Measured: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
Preservation of the cataract severity grade, assessed using LOCS III grading scale for nuclear domain beyond 3 months
Change in LOCS III = LOCS III (extended visit) - LOCS III (Visit 12, EB-CE-01 study)
Measured: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
Subjective assessment of Visual function and Quality-of-life will be defined by the Visual Function Index-14 (VF-14) questionnaire data collected an average 20 months following the end of treatment with the medical device initiated in the EB-CE-01 study
Change in Visual Function Index-14 (VF-14) Total Score (range 0-100, with higher scores representing better visual function) and changes in each of the 14 item-level scores (each item scored 0-4, with higher scores indicating less difficulty) from Visit 12 (EB-CE-01 study) to the extended follow-up visit
Measured: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start8 Nov 2025
- Primary completion17 Feb 2026
- Study completion17 Feb 2026
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 47 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246915
- Sponsor's protocol ID
- EB-CE-02
- Other IDs
- QM75-OSP-001
- Acronym
- EB-CE-02
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Extension Study on the Long-term Maintenance of Safety and Performance of the REVISYON SDS 100 Medical Device in Subjects With Mild-to-moderate Cataract
- ClinicalTrials.gov ID
- NCT07246915
- Acronym / sponsor ID
- EB-CE-02 / EB-CE-02
- Conditions
- Age-related Cataract, Vision Loss, Cataract, Mild Cataract, Moderate Cataract
- Keywords
- REVISYON SDS 100, Visual acuity, EB-CE-02, EB-CE-01, Long-term safety, Non-interventional, Extension study, Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Edinburgh Biosciences LtdIndustry (pharma, biotech, devices)
- Collaborators
- MDX Research
- Study start
- 8 Nov 2025 (actual)
- Primary completion
- 17 Feb 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 24 Nov 2025 (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.
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
Detailed description
This study is an ancillary study to the EB-CE-01 clinical investigation. No treatment or any study-specific intervention is foreseen for the study subcohort. This study is designed to evaluate the maintenance of safety and efficacy an average 20 months following the end of treatment of mild-to-moderate senile cataract with the medical device in the EB-CE-01 clinical investigation in the Romanian subcohort of subjects. Due to the long enrolment gap and different treatment intervals, the tracking of subjects provided a significant difference in the intervals since treatment completion among subjects.
Therefore, the study approach involves a single additional visit for subjects who initiated treatment, during which supplementary data will be collected from standard-of-care ophthalmological assessments.
In the initial EB-CE-01 study, treatment with the non-invasive medical device REVISYON SDS 100 was administered between April 2023 and December 2024 to 92 patients, all of whom were included in both the Full Analysis Set and the Safety Set. Best corrected visual acuity (BCVA) was assessed at 7 (±1) days, 28 (±4) days, and 84 (±10) days following the final treatment session (known as Visit 9). Treatment efficacy was evaluated at 7 (±1) days only, corresponding to one-week post-treatment.
In this extension study, prospective data will be collected to assess the incidence of any safety events and to evaluate the maintenance of best-corrected visual acuity (BCVA), cataract severity grade, and visual functioning at an additional follow-up visit. The following timepoints from the parent study will be used as reference: EB-CE-01 V0 (pre-treatment), EB-CE-01 V1-V9 (treatment visits), and EB-CE-01 V12 (last efficacy visit), which will serve as the baseline for the current extension study.
The main objective of the study is capturing any new clinically significant findings that meet the definition of an AE in accordance with EU MDR 2017/745 and ISO 14155:2020, as to generate robust safety findings in the pre-market stage.
As secondary objectives, the study will assess the mean change in best-corrected visual acuity (BCVA), the preservation of cataract severity grade, and the subjective evaluation of visual function using The Visual Function Index-14 (VF-14) relative to the last post-treatment assessment, defined at Visit 12 of the EB-CE-01 clinical investigation.
Study participants will be required to provide additional answers related to the visual functioning (VF-14 questionnaire), which will be administered in Romanian using linguistically validated versions. VF-14 questionnaire is a validated, brief questionnaire, including self-reported measures, designed to be completed within a few minutes, and is therefore not expected to constitute a burden or interfere with routine clinical care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –The study population will consist of adult subjects with vision loss due to mild or moderate cataract, who were previously treated with the medical device in the EB-CE-01 study (one eye only, recorded as the study eye). The exclusion criteria are intended to protect subject safety and to ensure the integrity and validity of the clinical investigation by excluding subjects for whom participation may present undue risk. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult subjects, affected by vision loss due to early-stage cataract who had been assessed for BCVA and LOCS III nuclear grade and underwent treatment during the EB-CE-01 clinical investigation
Key inclusion criteria (4 listed)
- Subjects who have initiated the EB-CE-01 study treatment phase in Romania
- Availability of complete retrospective data from the EB-CE-01 study- specifically from visit 12 assessment- including binocular BCVA, binocular LOCS III assessments, binocular slit-lamp assessment, and baseline assignment of the study eye.
- Be able and willing to follow instructions
- Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study. Note: Subjects who underwent cataract surgery in either eye will be allowed to participate
Key exclusion criteria (4 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 involved in other clinical investigation that may compromise the results of the study.
- Subjects developing mental illnesses that can influence their participation in the study (cognitive impairment, psychiatric condition, or neurological disorder).
- Any health condition which could interfere with the subject's ability to comply with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A summary of adverse events
Time frame: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
A summary of adverse events collected over an average of 20 months following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation. The types of adverse events to be collected (AEs, SADEs, USADEs, AESIs, and SAEs) will be classified by type, severity, outcome, seriousness and causality).
3 secondary outcomes
The mean change from Baseline post-treatment in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale
Time frame: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
Preservation of the cataract severity grade, assessed using LOCS III grading scale for nuclear domain beyond 3 months
Time frame: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
Subjective assessment of Visual function and Quality-of-life will be defined by the Visual Function Index-14 (VF-14) questionnaire data collected an average 20 months following the end of treatment with the medical device initiated in the EB-CE-01 study
Time frame: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),
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 18 Sep 2026.
- This is the website of Edinburgh Biosciences, the company sponsoring the clinical studies of the Revisyon medical device.Link provided by the sponsor.
- 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Cataract and Vision Loss, run by Edinburgh Biosciences Ltd at 6 sites in Romania.
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 4 inclusion and 4 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Romania. 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?
A summary of adverse events (time frame: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),). 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 18 Sep 2026.