Endothelial Cell Loss After Penetrating Keratoplasty

NCT04457063 | Completed Phase 2

• 1 other identifier: 0304624
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (3)

• Refraction

  Refractive measured by Diopter

  1 year

• Visual acuity

  The decimal snellens

  1 year

• Intra-ocular pressure

  mg

  1 year

Study Arms (1)

penetrating keratoplasty

EXPERIMENTAL

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

Procedure: PKP

Interventions

PKP 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

penetrating keratoplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction

You may not qualify if:

• Less than 18 and unable to give informed consent

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Ehab Mossallam, PhD

  Alexandria Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 15, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)