NCT01659801

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

August 1, 2012

Last Update Submit

April 8, 2021

Conditions

Cataract

Keywords

cataractcataract surgeryintaocular lenstoric lens

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Complications related to BunnyLens TR implantation duting cataract surgery

    3 monthes

Interventions

BunnyLens TRDEVICE

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

Also known as: toric inta-ocular lens

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Yaron Lang, MD

    Ha'Emek Medical Center, Afula Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

August 8, 2012

Study Start

May 21, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

April 13, 2021

Record last verified: 2021-04