Evaluation of the BunnyLens TR Intraocular Lens

Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens

With age, a human crystalline lens opacifies (cataract) disabling the eye in generating a clear, well contrasted image. The only therapeutic solution to this problem is surgical replacement of the crystalline lens with an intraocular lens (cataract surgery).

In addition to the cataract, the person might suffer from pre-existing cormeal astigmatism. In cases of severe corneal astigmatism, the standard IOL might not provide the optimal result, and additional surgical procedures as Incisional Keratotomy or Limbal Relaxing Incisions might be required.

BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism.

The BunnyLens TR IOL is designed for micro-incision cataract surgery (MICS), through 1.8mm incisions.

The aims of this study are to:

• Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism
• Exceed monocular best corrected distance visual acuity results provided in ISO guidelines.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: BunnyLens TR

Detailed Description

The reduction in refractive cylinder compared to pre-operative corneal astigmatism will be assessed using pre- and postoperative subjective refraction evaluation. Units of the measurement: diopters.

Monocular best corrected distance visual acuity will be assessed using ETDRS charts. Units of the measurement: logMAR.

There are no complications related to the BunnyLens TR implantation beyond those that might be expected in standard cataract surgery. The complications will be reported using Ocular condition forms included in the CRFs.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between 40 and 80 years of age, of either gender and any race;
• Have preoperative corneal astigmatism of >= 2 Dpt as determined by IOL Master keratometry;
• Have regular, bowtie shaped corneal astigmatism. Corneal topography printout should be approved and signed by cornea specialist.
• Anterior chamber depth is between 2.5 to 3.8 mm
• Axial length is between 22 to 26 mm
• are willing and able to understand and sign an informed consent;
• have age related cataracts that require extraction followed by implantation of a posterior chamber intraocular lens (IOL) and used as an on-label procedure;
• are able to obtain pupil dilation >=4.0 mm.

Exclusion Criteria:

• Following disease(s)/condition(s): choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, microphthalmos, proliferative diabetic retinopathy, corneal dystrophy, optic nerve atrophy, uncontrolled glaucoma or glaucoma treated by 3 or more medications, uncontrolled systemic disease or any ocular condition, that by opinion of investigator would compromise the refractive outcome or potential of the eye to achieve good vision.
• High intraocular pressure (above 25mmHg)
• Previous intraocular or corneal surgery;
• Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
• Current rigid contact lens usage (within 3 months prior to the preoperative biometry reading)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation	3 months
• Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Complications related to BunnyLens TR implantation duting cataract surgery	3 monthes

Collaborators and Investigators

• Sponsor: Hanita Lenses
• Investigators: Principal Investigator: Yaron Lang, MD, Ha'Emek Medical Center, Afula Israel

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 5, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: cataract; cataract surgery; intaocular lens; toric lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: BunnyLens TR 70 EMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No