Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

April 8, 2021 updated by: Hanita Lenses

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best corrected visual acuity 3 months after SeeLens AF implantation
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanita Lenses

Investigators

  • Principal Investigator: Yokrat Ton, MD, Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 18, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeeLensAF 65

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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