Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (… (NCT07246915) | Clinical Trial Compass
By InvitationNot Applicable
Long-term Safety & Performance of REVISYON SDS100 in Mild to Moderate Cataract: Extension Study (EB-CE-02)
Romania61 participantsStarted 2025-10-28
Plain-language summary
A non-interventional, extension study on the long-term maintenance of safety and performance of the REVISYON SDS 100 medical device in subjects with mild-to-moderate cataract.
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* Subjects who have initiated the EB-CE-01 study treatment phase in Romania
* Availability of complete retrospective data from the EB-CE-01 study- specifically from visit 12 assessment- including binocular BCVA, binocular LOCS III assessments, binocular slit-lamp assessment, and baseline assignment of the study eye.
* Be able and willing to follow instructions
* Subject whom the medical health history has been reviewed by the Investigator and medical records do not contraindicate the participation to the study. Note: Subjects who underwent cataract surgery in either eye will be allowed to participate
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 involved in other clinical investigation that may compromise the results of the study.
* Subjects developing mental illnesses that can influence their participation in the study (cognitive impairment, psychiatric condition, or neurological disorder).
* Any health condition which could interfere with the subject's ability to comply with the study.
What they're measuring
1
A summary of adverse events
Timeframe: An average 20 months (following the end of treatment with the medical device initiated in the EB-CE-01 clinical investigation),