CataractNCT01659801
Evaluation of the BunnyLens TR Intraocular Lens
A study testing BunnyLens TR in people with Cataract, run by Hanita Lenses.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- BunnyLens TR
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
About this study
Official title: Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens
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.
Read more
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.
Read the 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.
- Conditions
- Cataract
- Being tested
- BunnyLens TR
- Keywords
- cataract, cataract surgery, intaocular lens, toric lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BunnyLens TRDevice
Also called toric inta-ocular lens
BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism.
What is being measured
The primary outcome is the main question the study is designed to answer.
monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation
Measured: 3 months
• Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism
Measured: 3 months
Secondary outcomes (1)
Complications related to BunnyLens TR implantation duting cataract surgery
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study start21 May 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaron Lang, MD, Principal investigator, Ha'Emek Medical Center, Afula Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659801
- Sponsor's protocol ID
- BunnyLens TR 70 EMS
- Status last verified
- Apr 2021
- First submitted
- 1 Aug 2012
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens
- ClinicalTrials.gov ID
- NCT01659801
- Acronym / sponsor ID
- BunnyLens TR 70 EMS
- Conditions
- Cataract
- Keywords
- cataract, cataract surgery, intaocular lens, toric lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 21 May 2012 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BunnyLens TRAlso: toric inta-ocular lensBunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism. | Device | – |
Primary outcome
monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation
Time frame: 3 months
• Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism
Time frame: 3 months
1 secondary outcome
Complications related to BunnyLens TR implantation duting cataract surgery
Time frame: 3 monthes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Lang, MD principal investigator
Ha'Emek Medical Center, Afula Israel
Questions about this trial
What is this clinical trial studying?
A study testing BunnyLens TR in people with Cataract, run by Hanita Lenses.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.