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A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device | Clinical Trials | Clareo Health

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A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device

NCT04569318•Edinburgh Biosciences Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

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 55 and 85 years of age (inclusive) at the time of consent
•3. Best corrected visual acuity (BCVA) of 0.3 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. Subject with shallow anterior chamber
•4. Subject who have had a fluorescence angiogram or any use of fluorescein within the last 3 days
•5. Subject presenting eye infection or eye damage in either eye
•6. Subject routinely using contact lenses
•7. Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period
•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
+3 more criteria

Locations (1)

Dr.Solomatina Acu Centrs

Riga, Latvia

Key Dates

Start Date

October 19, 2020

Primary Completion Date

August 19, 2021

Completion Date

September 9, 2021

Last Updated

November 24, 2025

Enrollment

ACTUAL participants

Conditions

Cataract

Interventions

Treatment Beam

DEVICE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

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RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study To Assess A Novel Form Of Cataract Treatment Using The Non-Invasive REVISYON Proof-Of-Concept Device

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery