Using a new device to prevent complications in cataract surgery
Influence of CleaRing Open-capsule Device on Refractive Predictability in Cataract Patients (Part 2)
This study is testing a new device to see if it can help prevent complications after cataract surgery for patients getting the procedure on both eyes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Hanita Lenses Industry-sponsored |
| Locations | 1 site (Holon, Tel Aviv) |
| Trial ID | NCT06083025 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Hanita CleaRing device, an intraocular implant designed to inhibit posterior capsule opacification (PCO) in patients undergoing cataract surgery. The device is implanted into the capsular bag after the removal of the crystalline lens and before the insertion of the intraocular lens (IOL). By preventing PCO, the study aims to reduce the need for Nd:YAG laser treatment, which can have complications and economic implications. The trial focuses on patients who are candidates for bilateral cataract surgery and assesses the device's impact on visual outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 80 who are scheduled for bilateral cataract surgery and meet specific ocular criteria.
Not a fit: Patients with glaucoma, previous intraocular surgery, or certain corneal abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce the incidence of PCO and improve visual outcomes for cataract surgery patients.
How similar studies have performed: Previous studies have shown varying success with different approaches to preventing PCO, but the use of the CleaRing device represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Holon, Tel Aviv
- Wolfson Medical Center — Holon, Tel Aviv, Israel (Recruiting)
Study contacts
- Principal investigator: Guy Kleinmann, Prof. — Wolfson MC
- Study coordinator: Inbal Ratner
- Email: inbalr@wmc.gov.il
- Phone: 035028702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.