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NCT04457063 Clinical Trial

Endothelial Cell Loss After Penetrating Keratoplasty

Keratoconus Clinical Trial

Official title:
Endothelial Cell Loss Following Toric ICL Implantation for Correction of Myopia and Astigmatism After Penetrating Keratoplasty

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04457063
Other study ID # 0304624
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 1, 2018
Est. completion date June 15, 2020

Study information
Verified date June 2020
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 15, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PKP
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

Locations
Country Name City State
Egypt Alexandria Faculty of Medicine Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Refraction Refractive measured by Diopter 1 year
Primary Visual acuity The decimal snellens 1 year
Primary Intra-ocular pressure mg 1 year
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