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

Posterior Capsule Opacification Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 posterior capsular opacification (PCO) has decreased, it is still the most common complication following uneventful cataract surgery, with the rate of laser capsulotomy ranging from 10% to 37%1-5 ND:YAG capsulotomy is a highly successful treatment, but it is not free of complications, such as increased intraocular pressure (IOP), pitting or dislocation of the IOL, cystoid macular edema, and retinal detachment. PCO also places an economic burden on the healthcare system. The importance of PCO prevention has increased in recent years, due to the expanding popularity of premium IOLs. Patients implanted with a premium IOL usually have high demands with regard to outcome, and PCO can also have an earlier effect on the performance of a premium IOL (i.e., multifocal IOLs).

Previous attempts to prevent PCO have included investigations of various IOL materials and designs, surgical techniques, and pharmacological materials. Unexpectedly lower PCO rates were recently noticed in eyes that were implanted with a special type of IOL, e.g., the Synchrony IOL (AMO, Santa Ana, CA, USA)8 and the FluidVision IOL (PowerVision, Belmont, CA, USA). It was hypothesized that the capsular bag stayed open due to the special design of these IOLs, and that this should reduce the PCO rate. Based upon this concept, a special open capsule ring was designed for intracapsular implantation in an attempt to maintain the capsular bag open and to reduce PCO rate. Safety and efficacy of the device was demonstrated through several animal studies. The tested devices were effective in reducing posterior capsule opacification and Soemmering's ring formation by 69% to 77% compared to control group. The Hanita CleaRing device is designed to be implanted in the capsular bag together with a standard posterior chamber IOL in a minimally invasive cataract surgery. The device is intended to reduce posterior capsular opacification leading to reduced Nd:YAG treatment rate. The raw material of the device is a hydrophilic co-polymer, considered to be biocompatible and practically inert to the eye tissue. The objective of this study is to evaluate the safety and the efficacy of CleaRing device in cataract patients. ;

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Posterior Capsule Opacification

• NCT number: NCT06083025
• Study type: Interventional
• Source: Hanita Lenses
• Contact: Inbal Ratner
• Phone: 035028702
• Email: inbalr@wmc.gov.il
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Completion date: April 1, 2025