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Evaluation of the BunnyLens TR Intraocular Lens

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

BunnyLens TR

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, cataract surgery, intaocular lens, toric lens

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Outcomes

Primary Outcome Measures

monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation

• Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism

Secondary Outcome Measures

Complications related to BunnyLens TR implantation duting cataract surgery

Full Information

NCT ID

NCT01659801

First Posted

August 1, 2012

Last Updated

April 8, 2021

Sponsor

Hanita Lenses

1. Study Identification

Unique Protocol Identification Number

NCT01659801

Brief Title

Evaluation of the BunnyLens TR Intraocular Lens

Official Title

Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

May 21, 2012 (Actual)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanita Lenses

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

cataract, cataract surgery, intaocular lens, toric lens

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

BunnyLens TR

Other Intervention Name(s)

toric inta-ocular lens

Intervention Description

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

Primary Outcome Measure Information:

Title

monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation

Time Frame

3 months

Title

• Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Complications related to BunnyLens TR implantation duting cataract surgery

Time Frame

3 monthes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaron Lang, MD

Organizational Affiliation

Ha'Emek Medical Center, Afula Israel

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the BunnyLens TR Intraocular Lens

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