Status:
COMPLETED
A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
Lead Sponsor:
Hanita Lenses
Conditions:
Cataract
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The AssiAnchor 2 is a fixation ophthalmic device. The device is manufactured by Hanita Lenses from PMMA material which is being used for the production of Intra-ocular lenses. The device is intended ...
Detailed Description
Intended Use: The AssiAnchor is a device which is intended to be implanted permanently in the posterior chamber of the eye for fixation of subluxated capsule. Study Objectives: The primary aim of t...
Eligibility Criteria
Inclusion
- Requires capsule centration during or after cataract surgery.
- Understands the study requirements and the treatment procedures
- Sign Informed Consent before any study-specific tests or procedures.
Exclusion
- Diagnosed with active anterior segment intraocular inflammation.
- Obligated to participation in another clinical study within the past 30 days.
- Pregnant.
Key Trial Info
Start Date :
March 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03455114
Start Date
March 24 2018
End Date
June 9 2021
Last Update
March 2 2022
Active Locations (1)
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1
MeirMC
Kfar Saba, Israel