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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05494671
Enrollment
12
Registered
2022-08-10
Start date
2022-01-01
Completion date
2023-11-01
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Transplantation

Keywords

stem cell transplantation,, stem cell deficiency, CLAU

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.

Interventions

PROCEDUREconjunctival 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)

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

interventional case series

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the change of corneal epithelial thickness after stem cell transplantation over 9 months9 monthsCorneal 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026