Evaluation of Seelens AF, an Aspheric Intra-Ocular Lens
|ClinicalTrials.gov Identifier: NCT00825747|
Recruitment Status : Unknown
Verified January 2009 by Hanita Lenses.
Recruitment status was: Not yet recruiting
First Posted : January 21, 2009
Last Update Posted : January 21, 2009
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||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Aspheric SeeLens AF Intra-Ocular Lens.|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||January 2010|
Device: SeeLens AF intra-ocular lens
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825747
|Contact: Simha Siboniemail@example.com|
|Contact: Dorit Kelnerfirstname.lastname@example.org|
|Soroka University Medical Center||Not yet recruiting|
|Beer Sheva, Israel, 84101|
|Contact: Noam Yanculovich, MD 972-8-6400496 email@example.com|
|Principal Investigator: Noam Yanculovich, MD|
|Meir Medical Center||Not yet recruiting|
|Kfar-Saba, Israel, 44410|
|Contact: Yokrat Ton, MD 972-9-7472154 firstname.lastname@example.org|
|Contact: Ehud I Assia, MD 972-9-7471527 email@example.com|
|Principal Investigator: Yokrat Ton, MD|
|Sub-Investigator: Ehud Assia, MD|
|Sub-Investigator: Fani Segev, MD|
|Principal Investigator:||Yokrat Ton, MD||Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel|