Evaluation of the BunnyLens TR Intraocular Lens
Recruitment status was: Not yet recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of the Toric BuunyLens TR Intra-ocular Lens|
- monocular best corrected distance visual acuity results 3 months after BunnyLens TR implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- • Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Complications related to BunnyLens TR implantation duting cataract surgery [ Time Frame: 3 monthes ] [ Designated as safety issue: No ]
Device: BunnyLens TR
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659801
|Principal Investigator:||Yaron Lang, MD||Ha'Emek Medical Center, Afula Israel|