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Completed

NCT Number: NCT04457063

Endothelial Cell Loss After Penetrating Keratoplasty

This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Alexandria Faculty of Medicine

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PKP

Procedure
  • 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 outcomes

  1. Refraction

    Time frame: 1 year

    Refractive measured by Diopter

  2. Visual acuity

    Time frame: 1 year

    The decimal snellens

  3. Intra-ocular pressure

    Time frame: 1 year

    mg

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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