Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

Hanita Lenses

Status

Withdrawn

Conditions

Cataract

Treatments

Device: SeeLens AF intra-ocular lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT00825747

SeeLensAF 65

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Senile Cataract
Age >18 years
Cataract extraction using phacoemulsification
Corneal incision less than 1.5 mm

Exclusion criteria

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