Back to resultsEndothelial Cell Loss After Penetrating Keratoplasty
Primary Purpose
Keratoconus
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
PKP
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Exclusion Criteria:
- Less than 18 and unable to give informed consent
Sites / Locations
- Alexandria Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
penetrating keratoplasty
Arm Description
A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Outcomes
Primary Outcome Measures
Refraction
Refractive measured by Diopter
Visual acuity
The decimal snellens
Intra-ocular pressure
mg
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04457063
Brief Title
Endothelial Cell Loss After Penetrating Keratoplasty
Official Title
Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
Detailed Description
Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
penetrating keratoplasty
Arm Type
Experimental
Arm Description
A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Intervention Type
Procedure
Intervention Name(s)
PKP
Intervention Description
The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery.
TICL loading into the STAAR injector cartridge
Temporal clear corneal 3 mm incision & 2-side ports then viscoelastic injection into the AC
Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris.
Pupil constriction with A.Ch.
Washing the viscoelastic &Wound hydration.
Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks
Primary Outcome Measure Information:
Title
Refraction
Description
Refractive measured by Diopter
Time Frame
1 year
Title
Visual acuity
Description
The decimal snellens
Time Frame
1 year
Title
Intra-ocular pressure
Description
mg
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction
Exclusion Criteria:
Less than 18 and unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab Mossallam, PhD
Organizational Affiliation
Alexandria Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endothelial Cell Loss After Penetrating Keratoplasty
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