CompletedNot Applicable

Study On The Performance And Safety Of The REVISYON SDS 100 Device On Visual Acuity In Subjects With Cataract

Latvia, Lithuania114 participantsStarted 2022-06-28

Plain-language summary

Single arm, unmasked study to evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract.

Who can participate

Age range40 Years – 85 Years

SexALL

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Inclusion criteria

✓. Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS III grade 1 to 3 (moderate), as confirmed by the Investigator
✓. Subject aged between 40 and 85 years of age (inclusive) at the time of consent
✓. Best Corrected Visual Acuity (BCVA) of 0.3 LogMAR or worse due to cataract only
✓. Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study
✓. Subject who is judged suitable for the study after ophthalmic examination carried out by the Investigator
✓. 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

✕. 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 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
✕. Subjects with intraocular lens (IOL) implant in either eye
✕. Planned replacement of crystalline lens with intraocular lens (IOL) implant within the planned study period
✕. Subject with shallow anterior chamber
✕. Subject who have had a fluorescence angiogram or any use of fluorescein within the last 3 days
✕. Subject presenting eye infection or eye damage in either eye
✕. Any condition which could interfere with the subject's ability to comply with the study including participation in all study assessments and visits.

What they're measuring

Change in Visual Acuity

Timeframe: 4 weeks

Trial details

NCT IDNCT05396547

SponsorEdinburgh Biosciences Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-04

View on ClinicalTrials.gov More Age-related Cataract trials