NCT05670834

Brief Summary

The primary aim of this study is to investigate the potential association between MMP-2 gene polymorphism and susceptibility to cataract development in Egyptian patients. Furthermore, this study aims to compare between cataract patients and healthy controls by measuring the serum IL-6 concentration to evaluate its relationship with disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 15, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

December 15, 2022

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • MMP-2 gene (rs243865) polymorphism in cataract patients and healthy controls

    Matrix Metalloproteinase-2 Gene Polymorphism using real-time PCR

    1 year maximum

Secondary Outcomes (1)

  • compare between cataract patients and healthy controls by measuring the serum IL-6 concentration to evaluate its relationship with disease.

    1 year maximum

Study Arms (3)

control group (GroupA)

normal healthy non-cataractous volunteers aged ≥21 years

Genetic: genotyping assay by real-time PCRDiagnostic Test: ELISA

Group B (experimental group 1)

cataractous patients aged \>50 years and diagnosed with senile cataract.

Genetic: genotyping assay by real-time PCRDiagnostic Test: ELISA

Group C (experimental group 2)

cataractous patients aged ≥21 to 50 years and diagnosed with secondary cataract

Genetic: genotyping assay by real-time PCRDiagnostic Test: ELISA

Interventions

genotyping assay of MMP-2 gene with the real-time polymerase chain reaction

Group B (experimental group 1)Group C (experimental group 2)control group (GroupA)
ELISADIAGNOSTIC_TEST

. IL-6 level in serum will be analyzed by ELISA assay kit.

Group B (experimental group 1)Group C (experimental group 2)control group (GroupA)

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cataractous patients in Department of ophthalmology in Sohag University Hospitals and healthy controls of matched age and sex

You may qualify if:

  • Group A (control group) will include 30 eyes of 30 normal healthy non-cataractous volunteers aged ≥21 years. Group B (experimental group 1) will include 30 eyes of 30 cataractous patients aged \>50 years and diagnosed with senile cataract. Group C (experimental group 2) will include 30 eyes of 30 cataractous patients aged ≥21 to 50 years and diagnosed with secondary cataract. The control group will include participants who will be age-matched and sex-matched with the patients in the experimental groups

You may not qualify if:

  • concomitant eye pathology or inflammation, systemic diseases and previous eye or systemic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, 82519, Egypt

Location

Related Publications (1)

  • Dong Y, Mu GY, Chen F, Zhao RL, Wang M, Wang B. Correlation between MMP-2 gene polymorphism and cataract susceptibility. Eur Rev Med Pharmacol Sci. 2019 Apr;23(8):3167-3172. doi: 10.26355/eurrev_201904_17674.

    PMID: 31081067BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample will be obtained from all participants by withdrawing 3 mL of blood via venipuncture in EDTA tube

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 4, 2023

Study Start

July 1, 2023

Primary Completion

January 30, 2024

Study Completion

April 30, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations