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

Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05494671
• Other study ID #: N-14-2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with unilateral chemical ocular injury will be included in the study(12 eyes). 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).

The patient will be followed up at a week, a month, 3 months, 6months and 9 months postoperative.

Corneal epithelial mapping will be done at the previous schedule in both the donated and the recipient eyes using anterior segment OCT (Optical Coherence Tomography)

Exclusion criteria:

Bilateral cases and patients with severe conjunctival scaring and symblepharon.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: November 1, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients between 15 to 70 years

• Unilateral limbal stem cell deficiency

• Grade 4 stem cell deficiency

Exclusion Criteria:

• Cases with extensive symblepharon

• Cases with very poor visual acuity ( no light perception)

• Cases with posterior segment problem evident in ocular ultrasonography

Related Conditions & MeSH terms

• Limbal Stem Cell Deficiency
• Stem Cell Transplantation

Intervention

Procedure:
• conjunctival limbal autologous transplant
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)

Locations

Country	Name	City	State
Egypt	Kasr Alainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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