New device aims to sharpen vision without surgery in cataract patients
NCT ID NCT05396547
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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114 people
The number who actually took part.
- Started
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Jun 2022
- Finished
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Feb 2025
- Lead sponsor
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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
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CF Timisoara Clinical Hospital
Timișoara, 300173, Romania
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Clinica Vista, Ophtalmology Department
Timișoara, Romania
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Clinica de Oftalmologie Dr. Berghian
Timișoara, Romania
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Dr.Solomatina Acu Centrs
Riga, LV-1050, Latvia
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Lens-L Ltd
Liepāja, LV-3401, Latvia
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Opticlass Ophthalmology Clinic
Timișoara, 300012, Romania
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Spitalul Clinic de Urgențe Oftalmologice, Depatement of Ophthamology
Bucharest, Romania
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The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of Ophthalmology
Kaunas, Lithuania
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Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila
Cluj-Napoca, 400371, Romania
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Vilnius University Hospital Santaros Klinikos, Center of Eye Diseases
Vilnius, Lithuania
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Zielmelkurzeme Regional Hospital
Ventspils, LV - 3601, Latvia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which lens implant delivers sharper sight after cataract surgery?
- Seeing inside the eye during surgery: a new imaging tool could sharpen lens disease care
- Can Mix-and-Match lenses improve vision after cataract surgery?
- Can AI and a new eye scanner make cataract surgery results more predictable?
- Blue dye under the microscope: could a routine cataract tool damage corneal cells?
- A new lens design aims to improve vision after cataract surgery