Evaluation of Seelens AF, an Aspheric Intra-ocular Lens
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00825747|
Recruitment Status : Withdrawn (study was closed)
First Posted : January 21, 2009
Last Update Posted : April 13, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: SeeLens AF intra-ocular lens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.|
|Actual Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
- Device: SeeLens AF intra-ocular lens
the SeeLens AF is an acrylic hydrophilic C shaped haptics intra-ocular lens, designed for implantation in the lenticular capsular bag or the sulcus during cataract surgery.Other Name: aspheric SeeLens
- Best corrected visual acuity 3 months after SeeLens AF implantation [ Time Frame: 3 months ]
- Complications related to SeeLens AF implantation during cataract surgery. [ Time Frame: 3 months ]
- Postoperative severe intra-ocular inflammation or infection [ Time Frame: 3 months ]
- Prediction of ocular refraction after cataract surgery with Seelens AF implantation [ Time Frame: 3 months ]
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): 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|