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Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

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 July 2012 by Rabin Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718184
First Posted: October 31, 2012
Last Update Posted: October 31, 2012
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.
Collaborator:
Einat Medical Inc.
Information provided by (Responsible Party):
Rabin Medical Center
  Purpose
A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric intraocular lens in pseudophakic patients for correcting refractive errors following corneal transplantation

Condition Intervention
Refractive Error Corneal Implantation Intraocular Lens Implantation Procedure: toric intraocular lens implantation Procedure: Sulcoflex intraocular lens implantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Best corrected and uncorrected visual acuity [ Time Frame: 3 month ]
    Best corrected and uncorrected visual acuity following the IOL implantation


Secondary Outcome Measures:
  • Ocular complications [ Time Frame: 3 months ]
    pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration


Other Outcome Measures:
  • Refractive outcomes [ Time Frame: 3 months ]
    refractive outcomes following surgical intervention


Estimated Enrollment: 25
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sulcoflex
Sulcoflex intraocular lens implantation
Procedure: toric intraocular lens implantation
piggyback Sulcolflex toric intraocular lens implantation
Procedure: Sulcoflex intraocular lens implantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • after corneal transplantation with refractive errors
  • after cataract removal and intraocular lens implantation

Exclusion Criteria:

  • other ophthalmologic disorders limiting vision including glaucoma, AMD, profound amblyopia
  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): NCT01718184


Contacts
Contact: Irit Bahar, MD 972-3-9376101 iritbahar@gmail.com
Contact: Alon Zahavi, MD 972-3-9376101 alonzahavi@gmail.com

Locations
Israel
Rabin Medical Center Recruiting
Petah Tiqwa, Israel
Principal Investigator: Irit Bahar, MD         
Sponsors and Collaborators
Rabin Medical Center
Einat Medical Inc.
Investigators
Principal Investigator: Irit Bahar, MD Rabim Medical Center, Israel
  More Information

Publications:

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01718184     History of Changes
Other Study ID Numbers: RabinMC Sulcoflex Toric IOL
First Submitted: October 29, 2012
First Posted: October 31, 2012
Last Update Posted: October 31, 2012
Last Verified: July 2012

Keywords provided by Rabin Medical Center:
sulcoflex
toric
corneal implantation

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases