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Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

Primary Purpose

Refractive Error, Corneal Implantation, Intraocular Lens Implantation

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
toric intraocular lens implantation
Sulcoflex intraocular lens implantation
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring sulcoflex, toric, corneal implantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sulcoflex

Arm Description

Sulcoflex intraocular lens implantation

Outcomes

Primary Outcome Measures

Best corrected and uncorrected visual acuity
Best corrected and uncorrected visual acuity following the IOL implantation

Secondary Outcome Measures

Ocular complications
pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration

Full Information

First Posted
October 29, 2012
Last Updated
October 29, 2012
Sponsor
Rabin Medical Center
Collaborators
Einat Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01718184
Brief Title
Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
Collaborators
Einat Medical Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Corneal Implantation, Intraocular Lens Implantation
Keywords
sulcoflex, toric, corneal implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sulcoflex
Arm Type
Experimental
Arm Description
Sulcoflex intraocular lens implantation
Intervention Type
Procedure
Intervention Name(s)
toric intraocular lens implantation
Intervention Description
piggyback Sulcolflex toric intraocular lens implantation
Intervention Type
Procedure
Intervention Name(s)
Sulcoflex intraocular lens implantation
Primary Outcome Measure Information:
Title
Best corrected and uncorrected visual acuity
Description
Best corrected and uncorrected visual acuity following the IOL implantation
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Ocular complications
Description
pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Refractive outcomes
Description
refractive outcomes following surgical intervention
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irit Bahar, MD
Phone
972-3-9376101
Email
iritbahar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Zahavi, MD
Phone
972-3-9376101
Email
alonzahavi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irit Bahar, MD
Organizational Affiliation
Rabim Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tiqwa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irit Bahar, MD

12. IPD Sharing Statement

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Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation

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