Clinical trial NCT01659801: Evaluation of the BunnyLens TR Intraocular Lens
Official title: Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
cataract surgery
intaocular lens
toric lens
Lead sponsor: Hanita Lenses
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation
timeFrame: 3 months
measure: • Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism
timeFrame: 3 months
Secondary outcomes:
measure: Complications related to BunnyLens TR implantation duting cataract surgery
timeFrame: 3 monthes
Other outcomes:
Locations:
Study officials:
affiliation: Ha'Emek Medical Center, Afula Israel
name: Yaron Lang, MD
role: PRINCIPAL_INVESTIGATOR
References: