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Cataract device safety tracked over 20 months in extension study

NCT ID NCT07246915

Knowledge-focused Sponsor: Edinburgh Biosciences Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study follows 61 people who previously used the REVISYON SDS 100 device for mild-to-moderate cataract. Researchers will check for side effects and measure vision changes over about 20 months. No new treatment is given; the goal is to see if the device stays safe and works well long-term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REVISYON SDS 100 medical device
What this could lead to
If successful, this study could confirm that the device remains safe and effective over the long term for treating mild-to-moderate cataract.
What could go wrong
This is an observational extension study with no new treatment, so it cannot prove the device works better than other options. Results depend on data from a prior study and may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

47 people

The number who actually took part.

Started

Nov 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 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.

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Conditions

The condition(s) this trial relates to.

blindness (disorder) cataract senile cataract vision disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Age-related cataract Cataract Mild cataract Moderate cataract Vision loss

Contacts and locations

Locations

  • Dr. Berghian Ophthalmology Clinic

    Timișoara, Romania

  • Institutul Clinic de Urgențe Oftalmologice Prof. Dr. Mircea Olteanu

    Bucharest, Romania

  • Opticlass Clinic

    Timișoara, Romania

  • Romania Clinica Vista, Ophtalmology Department

    Timișoara, Romania

  • Spitalul Clinic CF Timisoara, Ophthalmology Department

    Timișoara, Romania

  • Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila

    Cluj-Napoca, Romania

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