BunnyLens TR
DeviceBunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism.
Other names: toric inta-ocular lens
NCT Number: NCT01659801
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.
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Notify Me40 year–80 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism.
Other names: toric inta-ocular lens
Time frame: 3 months
Time frame: 3 months
Time frame: 3 monthes
Hanita Lenses
Industry
Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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