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

NCT06083025 | Unknown DMC

• 1 other identifier: CR-0719 Part 2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Posterior Capsule Opacification

Keywords

Posterior capsule opacification; Cataract; Ring

Outcome Measures

Primary Outcomes (3)

• The first primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.

  Refractive will be evaluated by Automated refraction

  1, 3 and 5 years

• The second primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.

  Refractive will be evaluated by subjective refraction

  1, 3 and 5 years

• The third primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.

  Refractive will be evaluated by visual acuity measurement.

  1, 3 and 5 years

Secondary Outcomes (1)

• Secondary objective of this study is to evaluate the influence of the device on PCO rate

  1, 3 and 5 years

Study Arms (1)

CleaRing device for cataract patients

EXPERIMENTAL

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.

Device: CleaRing

Interventions

CleaRing DEVICE

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.

CleaRing device for cataract patients

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

Wolfson Medical Center

Holon, Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Guy Kleinmann, Prof.

  Wolfson MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inbal Ratner

CONTACT

035028702; inbalr@wmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a prospective, single group, single center, open label study. Each study subject will be implanted bilaterally with IOL of surgeon's choice (same IOL in both eyes) and CleaRing device in one eye.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 13, 2023
• Study Start: April 15, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)