Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cataract
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 80 years
- Gender
- Both males and females
Description
Study Design: This study is a prospective, single-group, single-center, open-label study. Each study subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye. Study population: Men and women designated for cataract surgery that meet the inclusion/exclusion criter...
Study Design: This study is a prospective, single-group, single-center, open-label study. Each study subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye. Study population: Men and women designated for cataract surgery that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study. Enrollment: A total of 20 subjects will be enrolled. Investigational sites: Single-center study. Duration of Subject participation: The primary endpoint will be achieved when the study subject has completed a 1-month follow-up after the implantation of the CleaRing device. Study Group: Each subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye. Visits & Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed. Complete anamnesis will be taken including the subject's medical complaints, medical history, medication use, and ophthalmic examinations. Surgical procedure: Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL. Follow-up: All subjects will have regular follow-up visits at the following post-operative periods: 1 day, 7 days, and 1 month. All postoperative visits will include a complete ophthalmic examination, a record of medications used, and documentation of adverse events.
Tracking Information
- NCT #
- NCT04838730
- Collaborators
- Not Provided
- Investigators
- Not Provided
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