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Evaluation of the BunnyLens TR Intraocular Lens

NCT01659801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Cataract

Interventions

DEVICE

BunnyLens TR

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

Sponsors & Collaborators

  • Hanita Lenses

    lead INDUSTRY

Principal Investigators

  • Yaron Lang, MD · Ha'Emek Medical Center, Afula Israel

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-21
Primary Completion
2015-05-31
Completion
2015-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01659801 on ClinicalTrials.gov