Phase
Condition
Vision Loss
Eye Disorders/infections
Eye Disease
Treatment
Treated with Ledinbio device
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject diagnosed with nuclear sclerotic (NS) lens opacities cataract, LOCS IIIgrade 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 andmedical records do not contraindicate the participation to the study
Subject who is judged suitable for the study after ophthalmic examination carriedout by the Investigator
Be able and willing to follow instructions, including participation in all studyassessments and visits, according to the opinion of the investigator - includingbeing able to sit upright for at least 20 mins (duration of the treatment)
Exclusion
Exclusion Criteria:
Subject unable to give voluntary written informed consent, is unlikely to cooperateor is legally incompetent, including subjects who are institutionalised by court orofficial order, or in a dependency relationship with sponsor, testing centre orinvestigator
Subject who had been clinically diagnosed with any eye diseases which may impactupon 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 withinthe planned study period
Subject with shallow anterior chamber
Subject who have had a fluorescence angiogram or any use of fluorescein within thelast 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 thestudy including participation in all study assessments and visits.
Subject who had undergone a treatment using photodynamic drugs within the last 30days. (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 theInvestigator, 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 hascompleted another investigational study within the last 30 days
Subject participated in the previous study with the LEDINBIO CE Device (EB-14-LAT)
Females who are pregnant or lactating
Females who are of childbearing potential (menses within the last 12 months) and nottaking adequate contraceptive precautions are excluded from the trial. Females ofchildbearing potential taking acceptable contraceptive precautions may be included.
Study Design
Study Description
Connect with a study center
Lens-L Ltd
Liepaja, LV-3401
LatviaSite Not Available
Dr.Solomatina Acu Centrs
Riga, LV-1050
LatviaSite Not Available
Zielmelkurzeme Regional Hospital
Ventspils, LV - 3601
LatviaSite Not Available
The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos, Department of Ophthalmology
Kaunas,
LithuaniaSite Not Available
Vilnius University Hospital Santaros Klinikos, Center of Eye Diseases
Vilnius,
LithuaniaSite Not Available
Spitalul Clinic de Urgențe Oftalmologice, Depatement of Ophthamology
Bucharest,
RomaniaSite Not Available
Vedis Ophthalmology Clinic | Ophthalmological Center Dr. Samoila
Cluj-Napoca, 400371
RomaniaSite Not Available
CF Timisoara Clinical Hospital
Timisoara, 300173
RomaniaSite Not Available
Clinica Vista, Ophtalmology Department
Timişoara,
RomaniaSite Not Available
Clinica de Oftalmologie Dr. Berghian
Timişoara,
RomaniaSite Not Available
Opticlass Ophthalmology Clinic
Timişoara, 300012
RomaniaSite Not Available
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