Studying Corneal Epithelial Stability Following Limbal Stem Cell Transplantation in Cases of Limbal Stem Cell Deficiency

NCT05494671 | Unknown DMC

• 1 other identifier: N-14-2022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Integrity of the corneal epithelium is the function of intact limbal stem cells. The reduction in the population of LSCs and their dysfunction result in abnormal corneal epithelialization and invasion of the corneal surface by the conjunctival epithelium with or without corneal neovascularization that is, limbal stem cell deficiency (LSCD). Different techniques have been developed to treat cases of limbal stem cell deficiency due to traumatic or congenital cases. Recent innovations developed to predict the early stages of stem cell deficiency. One of these methods is measurement of the central epithelial thickness as it was found that limbal stem cell deficiency causes reduction of the central epithelial thickness. The aim of this study is to study changes in the corneal epithelial thickness at different quadrants of the cornea to observe the exact time of epithelial stability following stem cell transplantation.

Conditions

Stem Cell Transplantation

Keywords

stem cell transplantation,; stem cell deficiency; CLAU

Outcome Measures

Primary Outcomes (1)

• the change of corneal epithelial thickness after stem cell transplantation over 9 months

  Corneal epithelial mapping will be done at one month, 3,6 and 9 months in both the donated and the recipient eyes using anterior segment OCT at the center

  9 months

Study Arms (1)

conjunctival limbal autologous transplant

EXPERIMENTAL

patients with unilateral stem cell deficiency due to chemical burn

Procedure: conjunctival limbal autologous transplant

Interventions

conjunctival limbal autologous transplant PROCEDURE

Patients with unilateral chemical ocular injury will be included in the study. All selected patients will receive a thorough explanation of the study design and aims and informed consent will be obtained in all patients. Eyes of all participants will be subjected to: Best corrected visual acuity, Slit lamp examination and ocular ultrasound if no fundus view. Staging of degree of limbal stem cell deficiency is done by Roper Hall classification and then the patient will have conjunctival limbal autologous transplant (CLAU)

conjunctival limbal autologous transplant

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 15 to 70 years
• Unilateral limbal stem cell deficiency
• Grade 4 stem cell deficiency

You may not qualify if:

• Cases with extensive symblepharon
• Cases with very poor visual acuity ( no light perception)
• Cases with posterior segment problem evident in ocular ultrasonography

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: interventional case series

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 10, 2022
• Study Start: January 1, 2022
• Primary Completion: January 10, 2023
• Study Completion: November 1, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

EG (1)