Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 August 21, 2014