Influence of CleaRing Open-capsule Device on Refractive Predictability in Cataract Patients (Part 2)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 extraction of the crystalline lens and prior to implantation of the IOL. The device is manufactured by Hanita Lenses from a hydrophilic acrylic co-polymer which is being used for the production of Intra-ocular lenses.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Israel
Wolfson Medical Center
RECRUITING
Holon
Contact Information
Primary
Inbal Ratner
inbalr@wmc.gov.il
035028702
Time Frame
Start Date: 2023-04-15
Estimated Completion Date: 2025-04-01
Participants
Target number of participants: 25
Treatments
Experimental: CleaRing device for cataract patients
All subjects who meet eligibility requirements will be asked to participate. Subjects will be considered enrolled into the study after:~1. A signed Informed Consent has been obtained.~2. The subject has met all of the inclusion and none of the exclusion criteria.~3. The ability of the subject to safely undergo cataract surgery under local anesthesia was confirmed by the investigator, according to standard procedure of the medical center.
Related Therapeutic Areas
Sponsors
Leads: Hanita Lenses

This content was sourced from clinicaltrials.gov

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