Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of the Aspheric SeeLens AF Intra-ocular Lens.

Conditions
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Cataract

Intervention / Treatment
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* Device: SeeLens AF intra-ocular lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity 3 months after SeeLens AF implantation |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related to SeeLens AF implantation during cataract surgery. |  | 3 months | 
| Postoperative severe intra-ocular inflammation or infection |  | 3 months | 
| Prediction of ocular refraction after cataract surgery with Seelens AF implantation |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Cataract surgery, intraocular lens, Aspheric lens