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New device aims to sharpen vision without surgery in cataract patients

NCT ID NCT05396547

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called REVISYON SDS 100 to see if it can safely improve vision in people with age-related cataracts without surgery. 114 adults with moderate cataracts used the device, and researchers measured changes in eyesight and cataract severity. The goal was to find a non-invasive way to manage vision loss from cataracts.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

114 people

The number who actually took part.

Started

Jun 2022

Finished

Feb 2025

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.

Ages

40 to 85 years

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: 1. Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator 2. Subject aged between 40 and 85 years of age (inclusive) at the time of consent 3. Best Corrected Visual Acuity (BCVA) of 0.3 LogMAR or worse due to cataract only 4. Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study 5. Subject who is judged suitable for the study after ophthalmic examination carried out by the Investigator 6. 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: 1. 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 2. 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 3. Subjects with intraocular lens (IOL) implant in either eye 4. Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period 5. Subject with shallow anterior chamber 6. Subject who have had a fluorescence angiogram or any use of fluorescein within the last 3 days 7. Subject presenting eye infection or eye damage in either eye 8. Any condition which could interfere with the subject's ability to comply with the study including participation in all study assessments and visits. 9. 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) 10. 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 11. Subject currently receiving treatment in another investigational study or has completed another investigational study within the last 30 days 12. Subject participated in the previous study with the REVISYON Device (EB-14-LAT) 13. Females who are pregnant or lactating 14. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CF Timisoara Clinical Hospital

    Timișoara, 300173, Romania

  • Clinica Vista, Ophtalmology Department

    Timișoara, Romania

  • Clinica de Oftalmologie Dr. Berghian

    Timișoara, Romania

  • Dr.Solomatina Acu Centrs

    Riga, LV-1050, Latvia

  • Lens-L Ltd

    Liepāja, LV-3401, Latvia

  • Opticlass Ophthalmology Clinic

    Timișoara, 300012, Romania

  • Spitalul Clinic de Urgențe Oftalmologice, Depatement of Ophthamology

    Bucharest, Romania

  • The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of Ophthalmology

    Kaunas, Lithuania

  • Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila

    Cluj-Napoca, 400371, Romania

  • Vilnius University Hospital Santaros Klinikos, Center of Eye Diseases

    Vilnius, Lithuania

  • Zielmelkurzeme Regional Hospital

    Ventspils, LV - 3601, Latvia

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