Endothelial Cell Loss After Penetrating Keratoplasty

NCT ID: NCT04457063

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-06-15

Brief Summary

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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

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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.

Conditions

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Keratoconus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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penetrating keratoplasty

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

Group Type EXPERIMENTAL

PKP

Intervention Type PROCEDURE

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

Interventions

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PKP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ehab Mossallam, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria Faculty of Medicine

Locations

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Alexandria Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0304624

Identifier Type: -

Identifier Source: org_study_id

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