Evaluation of Seelens AF, an Aspheric Intra-Ocular Lens
Recruitment status was: Not yet recruiting
Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.
Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.
Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.
Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.
|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 Aspheric SeeLens AF Intra-Ocular Lens.|
- Best corrected visual acuity 3 months after SeeLens AF implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Complications related to SeeLens AF implantation during cataract surgery. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Postoperative severe intra-ocular inflammation or infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Prediction of ocular refraction after cataract surgery with Seelens AF implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Device: SeeLens AF intra-ocular lens
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825747
|Soroka University Medical Center|
|Beer Sheva, Israel, 84101|
|Meir Medical Center|
|Kfar-Saba, Israel, 44410|
|Principal Investigator:||Yokrat Ton, MD||Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel|