Evaluation of Seelens AF, an Aspheric Intra-Ocular Lens - Full Text View

Sponsored by:	Hanita Lenses
Information provided by:	Hanita Lenses
ClinicalTrials.gov Identifier:	NCT00825747

Purpose

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.

Condition	Intervention	Phase
Cataract	Device: SeeLens AF intra-ocular lens	Phase III

MedlinePlus related topics: Cataract Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Evaluation of the Aspheric SeeLens AF Intra-Ocular Lens.

Further study details as provided by Hanita Lenses:

Primary Outcome Measures:

Best corrected visual acuity 3 months after SeeLens AF implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complications related to SeeLens AF implantation during cataract surgery. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Postoperative severe intra-ocular inflammation or infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Prediction of ocular refraction after cataract surgery with Seelens AF implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825747

Contacts

Contact: Simha Siboni	972-52-3749535	simha@hanitalenses.com
Contact: Dorit Kelner	972-52-4239162	dorit@hanitalenses.com

Locations

Israel
Meir Medical Center
Kfar-Saba, Israel, 44410
Soroka University Medical Center
Beer Sheva, Israel, 84101

Sponsors and Collaborators

Hanita Lenses

Investigators

Principal Investigator:

Yokrat Ton, MD

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

More Information

No publications provided

Responsible Party:	Hanita Lenses, Israel ( Simha Siboni, regulatory manager )
Study ID Numbers:	SeeLensAF 65
Study First Received:	January 18, 2009
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00825747 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by Hanita Lenses:

Cataract
Cataract surgery
intraocular lens
Aspheric lens

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009