Status:
UNKNOWN
Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients
Lead Sponsor:
Hanita Lenses
Conditions:
Cataract
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
CleaRing is intended to reduce posterior capsular opacification in cataract patients. The device is intended to be implanted together with standard posterior chamber IOL during cataract surgery.
Detailed 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. St...
Eligibility Criteria
Inclusion
- The subject is between 50 and 80 years of age The subject is designated for cataract surgery
- Eye designated for the study fulfills the following criteria:
- Potentially able to achieve a good vision (by the opinion of the investigator)
- ACD is at least 2.5mm (from epithelium)
- Corneal astigmatism is at most 2.0 DPT
- Axial length is between 22.0 and 26.0 mm
- Able to obtain pupil dilation of at least 6.0 mm
- Average keratometry values between 42.0 and 46.0 D Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
Exclusion
- Subject diagnosed with glaucoma of any type or having intraocular pressure above 24mmHg
- Subject who has undergone previous intraocular surgery in eye designated for the study
- Subject with a corneal abnormality that would prevent stable and reliable refraction
- Subject with weak or torn zonules
- Subject with Pseudoexfoliation syndrome (PEX)
- Subject with amblyopia
- Subject with a retinal disease that in the opinion of the principal investigator would prevent stable and reliable refraction or might be worsened due to implantation of the device
- Subject is diagnosed with active anterior segment intraocular inflammation
- Subject is obligated to previous participation in another study with any investigational drug or device within the past 30 days
- Subject is pregnant
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04838730
Start Date
January 1 2019
End Date
January 1 2023
Last Update
April 9 2021
Active Locations (1)
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1
Wolfson
Holon, Israel