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Evaluation of Seelens AF, an Aspheric Intra-Ocular Lens

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Hanita Lenses.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825747
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hanita Lenses
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Aspheric SeeLens AF Intra-Ocular Lens.

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Complications related to SeeLens AF implantation during cataract surgery. [ Time Frame: 3 months ]
  • Postoperative severe intra-ocular inflammation or infection [ Time Frame: 3 months ]
  • Prediction of ocular refraction after cataract surgery with Seelens AF implantation [ Time Frame: 3 months ]

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:
    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.
    Other Name: aspheric SeeLens
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825747


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

Locations
Israel
Soroka University Medical Center Not yet recruiting
Beer Sheva, Israel, 84101
Contact: Noam Yanculovich, MD    972-8-6400496    yanculov@bgu.ac.il   
Principal Investigator: Noam Yanculovich, MD         
Meir Medical Center Not yet recruiting
Kfar-Saba, Israel, 44410
Contact: Yokrat Ton, MD    972-9-7472154    barakton@013.net.il   
Contact: Ehud I Assia, MD    972-9-7471527    assia@netvision.net.il   
Principal Investigator: Yokrat Ton, MD         
Sub-Investigator: Ehud Assia, MD         
Sub-Investigator: Fani Segev, MD         
Sponsors and Collaborators
Hanita Lenses
Investigators
Principal Investigator: Yokrat Ton, MD Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel
  More Information

Responsible Party: Simha Siboni, regulatory manager, Hanita Lenses, Israel
ClinicalTrials.gov Identifier: NCT00825747     History of Changes
Other Study ID Numbers: SeeLensAF 65
First Submitted: January 18, 2009
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
Last Verified: January 2009

Keywords provided by Hanita Lenses:
Cataract
Cataract surgery
intraocular lens
Aspheric lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases