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Endothelial Cell Loss After Penetrating Keratoplasty

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04457063
Enrollment
8
Registered
2020-07-07
Start date
2018-07-01
Completion date
2020-06-15
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

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.

Interventions

PROCEDUREPKP

1. The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery. 2. TICL loading into the STAAR injector cartridge 3. Temporal clear corneal 3 mm incision & 2-side ports then viscoelastic injection into the AC 4. 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. 5. Pupil constriction with A.Ch. 6. Washing the viscoelastic &Wound hydration. 7. Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Refraction1 yearRefractive measured by Diopter
Visual acuity1 yearThe decimal snellens
Intra-ocular pressure1 yearmg

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026