Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06083025 |
| Other study ID # |
CR-0719 Part 2 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2023 |
| Est. completion date |
April 1, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Hanita Lenses |
| Contact |
Inbal Ratner |
| Phone |
035028702 |
| Email |
inbalr[@]wmc.gov.il |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
