Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

NCT ID: NCT00825747

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-01-31

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.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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aspheric SeeLens

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanita Lenses

INDUSTRY

Sponsor Role lead

Responsible Party

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Hanita Lenses, Israel

Principal Investigators

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Yokrat Ton, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status

Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SeeLensAF 65

Identifier Type: -

Identifier Source: org_study_id

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