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

NCT05396547 | Completed

• 1 other identifier: EB-CE-01
• Study Type: interventional
• Target: 114
• Locations: 3 countries
• Sites: 11

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.

Conditions

Age-related Cataract

Keywords

non-invasive cataract treatment, N-LOCS III grade 1 to 3

Outcome Measures

Primary Outcomes (1)

• Change in Visual Acuity

  Change in Best Corrected Visual Acuity (BCVA), assessed using LogMAR scale.

  4 weeks

Secondary Outcomes (2)

• Change in Cataract Severity

  4 weeks

• Subjective satisfaction using Visual Function Index

  4 weeks

Study Arms (1)

Treated

EXPERIMENTAL

Treatment with REVISYON SDS 100 Device

Device: Treated with REVISYON SDS 100 Device

Interventions

Treated with REVISYON SDS 100 Device DEVICE

Treated with REVISYON SDS 100 Device

Treated

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edinburgh Biosciences Ltd: lead
• MDX Research: collaborator

Study Sites (11)

Lens-L Ltd

Liepāja, LV-3401, Latvia

Location

Dr.Solomatina Acu Centrs

Riga, LV-1050, Latvia

Location

Zielmelkurzeme Regional Hospital

Ventspils, LV - 3601, Latvia

Location

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

Kaunas, Lithuania

Location

Vilnius University Hospital Santaros Klinikos, Center of Eye Diseases

Vilnius, Lithuania

Location

Spitalul Clinic de Urgențe Oftalmologice, Depatement of Ophthamology

Bucharest, Romania

Location

Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila

Cluj-Napoca, 400371, Romania

Location

Opticlass Ophthalmology Clinic

Timișoara, 300012, Romania

Location

CF Timisoara Clinical Hospital

Timișoara, 300173, Romania

Location

Clinica de Oftalmologie Dr. Berghian

Timișoara, Romania

Location

Clinica Vista, Ophtalmology Department

Timișoara, Romania

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Trevor Shields

  Edinburgh Biosciences Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm interventional study

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: June 28, 2022
• Primary Completion: January 4, 2025
• Study Completion: February 2, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

LA (3); RO (6); LI (2)