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

NCT ID: NCT05494671

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-11-01

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.

Detailed 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.

Conditions

Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

conjunctival limbal autologous transplant

patients with unilateral stem cell deficiency due to chemical burn

Group Type: EXPERIMENTAL

conjunctival limbal autologous transplant

Intervention Type: 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)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Fayrouz Aboalazayem

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr Alainy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-14-2022

Identifier Type: -

Identifier Source: org_study_id