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Evaluation of the BunnyLens TR Intraocular Lens

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hanita Lenses.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hanita Lenses
ClinicalTrials.gov Identifier:
NCT01659801
First received: August 1, 2012
Last updated: August 5, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention Phase
Cataract
Device: BunnyLens TR
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens

Resource links provided by NLM:


Further study details as provided by Hanita Lenses:

Primary Outcome Measures:
  • monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • • Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications related to BunnyLens TR implantation duting cataract surgery [ Time Frame: 3 monthes ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Intervention Details:
    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.
    Other Name: toric inta-ocular lens
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659801

Contacts
Contact: zoya zilberfarb 972525244144 zoya@hanitalenses.com
Contact: yakir kushlin 972524239100

Sponsors and Collaborators
Hanita Lenses
Investigators
Principal Investigator: Yaron Lang, MD Ha'Emek Medical Center, Afula Israel
  More Information

No publications provided

Responsible Party: Hanita Lenses
ClinicalTrials.gov Identifier: NCT01659801     History of Changes
Other Study ID Numbers: BunnyLens TR 70 EMS
Study First Received: August 1, 2012
Last Updated: August 5, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Hanita Lenses:
cataract
cataract surgery
intaocular lens
toric lens

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 24, 2014