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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06042296
Other study ID # BAUNHYILDIRIM-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date January 2024

Study information

Verified date September 2023
Source Balikesir University
Contact HÜMEYRA YILDIRIM
Phone 05305244841
Email balikesirhumeyra@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may extend into the central cornea, inducing irregular corneal astigmatism and causing loss of vision. CD44( phagocytic glycoprotein-1 ) is involved in the organization of certain cellular processes, for instance, cell adhesion, division, and migration, by binding with its main ligand, hyaluronic acid. Proliferating cell nuclear antigen (PCNA) is a proliferation marker in the nucleus. E-cadherin is a calcium-dependent transmembrane glycoprotein that plays a significant role in the protection of tissue integrity and cell-to-cell adhesion. This study aimed to determine the role of CD44, proliferating cell nuclear antigen (PCNA), and E-cadherin in pterygium formation and recurrence.


Description:

Methods:60 patients with pterygium will be enrolled in the study and conjunctival samples will be collected from 30 patients to form the control group. CD44, PCNA and E-cadherin expressions in surgically removed pterygium will be compared with tissue samples from normal control group. IBM SPSS (statistical software) version 26.0 will be used for statistical analyses.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: patient with pterygium - Exclusion Criteria: patient with pseudopterygium -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Expression of CD44, E-cadherin and PCNA
The investigators use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval. Histopathological and immunohistochemical staining findings will be reported using a Nikon light microscope and an image analysis system (Nikon Instruments Europe BV)

Locations

Country Name City State
Turkey Hümeyra Yildirim Balikesir

Sponsors (1)

Lead Sponsor Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunohistochemistry Thin sections will be taken from paraffin embedded tissue samples and placed on barcode glass slides After deparaffinization and rehydration, the sections will be subjected to histopathological evaluation using hematoxylin and eosin staining.We use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval up to three weeks after pterygium surgery
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