NCT04838730

Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hanita Lenses · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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. Study population: Men and women designated for cataract surgery that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study. Enrollment: A total of 20 subjects will be enrolled. Investigational sites: Single-center study. Duration of Subject participation: The primary endpoint will be achieved when the study subject has completed a 1-month follow-up after the implantation of the CleaRing device. Study Group: Each subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye. Visits \& Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed. Complete anamnesis will be taken including the subject's medical complaints, medical history, medication use, and ophthalmic examinations. Surgical procedure: Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL. Follow-up: All subjects will have regular follow-up visits at the following post-operative periods: 1 day, 7 days, and 1 month. All postoperative visits will include a complete ophthalmic examination, a record of medications used, and documentation of adverse events.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Surgical procedure	Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2021-04-09
• Last updated: 2021-04-09

Locations

1 site across 1 country: Israel