Evaluation of Seelens AF, an Aspheric Intra-ocular Lens
NCT ID: NCT00825747
Last Updated: 2021-04-13
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2009-01-31
2010-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
* Cataract extraction using phacoemulsification
* Corneal incision less than 1.5 mm
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Hanita Lenses
INDUSTRY
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
Meir Medical Center
Kfar Saba, , Israel
Countries
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Other Identifiers
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SeeLensAF 65
Identifier Type: -
Identifier Source: org_study_id
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