Evaluation of Seelens AF, an Aspheric Intra-ocular Lens
- Conditions
- Cataract
- Registration Number
- NCT00825747
- Lead Sponsor
- Hanita Lenses
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Senile Cataract
- Age >18 years
- Cataract extraction using phacoemulsification
- Corneal incision less than 1.5 mm
- Allergy/sensitivity to eye drops used during and after cataract surgery
- Amblyopia/ strabismus
- Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.
- previous ocular surgery or ocular trauma in the investigated eye
- Ocular anomaly, such as microphthalmos
- Keratometry values less than 40 diopters or more than 47 diopters.
- Ocular axial length less than 21.0 mm or longer than 25.0 mm
- Intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule.
- posterior capsular scar
- visual acuity in the fellow eye less than 20/200
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Best corrected visual acuity 3 months after SeeLens AF implantation 3 months
- Secondary Outcome Measures
Name Time Method Complications related to SeeLens AF implantation during cataract surgery. 3 months Prediction of ocular refraction after cataract surgery with Seelens AF implantation 3 months Postoperative severe intra-ocular inflammation or infection 3 months
Trial Locations
- Locations (2)
Soroka University Medical Center
🇮🇱Beer Sheva, Israel
Meir Medical Center
🇮🇱Kfar-Saba, Israel
Soroka University Medical Center🇮🇱Beer Sheva, Israel