Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

This study is currently recruiting participants.
Verified July 2012 by Rabin Medical Center
Sponsor:
Collaborator:
Einat Medical INC
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01718184
First received: October 29, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Best corrected and uncorrected visual acuity following the IOL implantation


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


Other Outcome Measures:
  • Refractive outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 29, 2012
Last Updated: October 29, 2012
Health Authority: Israel: Rabin Medical Center

Keywords provided by Rabin Medical Center:
sulcoflex
toric
corneal implantation

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 14, 2014