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Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

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ClinicalTrials.gov Identifier: NCT01718184
Recruitment Status : Unknown
Verified July 2012 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Refractive Error Corneal Implantation Intraocular Lens Implantation Procedure: toric intraocular lens implantation Procedure: Sulcoflex intraocular lens implantation

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2012
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sulcoflex
Sulcoflex intraocular lens implantation
Procedure: toric intraocular lens implantation
piggyback Sulcolflex toric intraocular lens implantation
Procedure: Sulcoflex intraocular lens implantation


Outcome Measures

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


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


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


Eligibility Criteria

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 Posted: October 31, 2012    Key Record Dates
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