Status:
COMPLETED
Study On The Performance And Safety Of The REVISYON SDS 100 Device On Visual Acuity In Subjects With Cataract
Lead Sponsor:
Edinburgh Biosciences Ltd
Collaborating Sponsors:
MDX Research
Conditions:
Age-related Cataract
Eligibility:
All Genders
40-85 years
Phase:
NA
Brief 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.
Detailed Description
This single arm, unmasked study will evaluate the performance and safety of the REVISYON SDS 100 Device for the non-invasive treatment of vision loss in age-related cataract. Only one of the subject'...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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)
- 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
- Subject currently receiving treatment in another investigational study or has completed another investigational study within the last 30 days
- Subject participated in the previous study with the REVISYON Device (EB-14-LAT)
- Females who are pregnant or lactating
- 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.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2025
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05396547
Start Date
June 28 2022
End Date
February 2 2025
Last Update
November 24 2025
Active Locations (11)
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1
Lens-L Ltd
Liepāja, Latvia, LV-3401
2
Dr.Solomatina Acu Centrs
Riga, Latvia, LV-1050
3
Zielmelkurzeme Regional Hospital
Ventspils, Latvia, LV - 3601
4
The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of Ophthalmology
Kaunas, Lithuania