NCT06042296

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 10, 2023

Last Update Submit

September 15, 2023

Conditions

Keywords

PCNA,cd44e-cadherinimmunohistochemistrypterygium

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

control group

group 1 -control group normal conjunctiva from 30 patients

Other: Expression of CD44, E-cadherin and PCNA

group 2 primary pterygia

primary pterygia samples from 30 patients

Other: Expression of CD44, E-cadherin and PCNA

group 3 recurrent pterygia

recurrent pterygia samples from 30 patients

Other: Expression of CD44, E-cadherin and PCNA

Interventions

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)

control groupgroup 2 primary pterygiagroup 3 recurrent pterygia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60 patient with primary and recurrent pterygium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hümeyra Yildirim

Balıkesir, 10100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pterygium

Interventions

CadherinsProliferating Cell Nuclear Antigen

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cell Adhesion MoleculesMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsAntigens, SurfaceAntigensBiological FactorsNuclear ProteinsAntigens, NuclearBiomarkers, TumorBiomarkers

Study Officials

  • HÜMEYRA YILDIRIM

    Balıkesir Medical Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Expression of CD44, PCNA and E-cadherin in pterygium tissue

Study Record Dates

First Submitted

September 10, 2023

First Posted

September 18, 2023

Study Start

October 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations