Status:
UNKNOWN
Influence of CleaRing Open-capsule Device on Refractive Predictability in Cataract Patients (Part 2)
Lead Sponsor:
Hanita Lenses
Conditions:
Posterior Capsule Opacification
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
The Hanita CleaRing device is an intraocular implant designed for inhibition of PCO leading to reduction in the Nd:YAG treatment rate. The device is implanted into the capsular bag after the extractio...
Detailed Description
Cataract surgery has undergone significant improvement in terms of surgical technique, instrumentation and the quality of intraocular lenses (IOLs) over the past decades. Although the rate of posterio...
Eligibility Criteria
Inclusion
- Subject is between 50 and 80 years of age
- Subject is designated for bilateral cataract surgery
- Both eyes fulfil the following criteria:
- Potentially able to achieve a good vision (by 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
- Subject with 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 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 :
April 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06083025
Start Date
April 15 2023
End Date
April 1 2025
Last Update
October 13 2023
Active Locations (1)
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1
Wolfson Medical Center
Holon, Tel Aviv, Israel