Evaluation of the BunnyLens TR Intraocular Lens
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|ClinicalTrials.gov Identifier: NCT01659801|
Recruitment Status : Unknown
Verified August 2012 by Hanita Lenses.
Recruitment status was: Not yet recruiting
First Posted : August 8, 2012
Last Update Posted : August 8, 2012
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 or disease||Intervention/treatment||Phase|
|Cataract||Device: BunnyLens TR||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens|
Device: BunnyLens TR
- 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 ]
- Complications related to BunnyLens TR implantation duting cataract surgery [ Time Frame: 3 monthes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659801
|Contact: zoya email@example.com|
|Contact: yakir kushlin||972524239100|
|Principal Investigator:||Yaron Lang, MD||Ha'Emek Medical Center, Afula Israel|