CataractNCT05670834
Association Between Matrix Metalloproteinase-2 Gene Polymorphism rs243865 and Susceptibility to Cataract Development
An observational study of Cataract, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- genotyping assay by real-time PCR and ELISA
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Study population: cataractous patients in Department of ophthalmology in Sohag University Hospitals and healthy controls of matched age and sex
Who may be able to join
- 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
Who cannot join
- concomitant eye pathology or inflammation, systemic diseases and previous eye or systemic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Cataract is a leading cause of blindness worldwide and is more common in low socioeconomic states and developing countries. According to the WHO, among 3 million visually impaired and 1 million blind persons in Egypt, about 60% have cataract.
The lens undergoes several morphological, biochemical, and physical changes with age which are causal for the formation of age-related cataract.
Oxidative stress can directly influence the solubility of the lens proteins, which increases the lens's opacity.
some studies suggest that inflammatory response may be involved in the occurrence of catarac. and that the pathophysiology is largely attributed to peptide mediators, such as transforming growth factor-beta (TGF-β), epidermal growth factor (EGF) and matrix metalloproteinases (MMPs), with the inhibition of these and other related molecules showing promising results.
Matrix metalloproteinases (MMPs) are a kind of calcium-zinc ion-dependent proteolytic enzyme involved in a variety of cellular processes. MMPs are well known for their ability to degrade the extracellular matrix (ECM) and are involved in several intracellular mechanisms from cell differentiation, proliferation, and angiogenesis to apoptosis.
Several studies' results suggest that the rs243865 (16q13-q21) polymorphism in the promoter region of the metalloproteinase-2 (MMP-2) gene is associated with ophthalmological disorders such as age-related macular degeneration. A recent study suggested that the MMP-2 rs243865 (C/T) polymorphism is associated with an increased risk of cataract.
The expression and activation of MMP-2 can be regulated by environmental influences from surrounding stroma, such as cytokines. some studies suggest that IL6 upregulates the expression of MMPs including MMP-2.
IL-6 is a soluble mediator with a pleiotropic effect on inflammation, immune response, and hematopoiesis. high levels of Il-6 in cataract patients may support the inflammatory response theory of disease development.
this study will follow the tenets of the Declaration of Helsinki. All study participants will sign informed written consent before enrolment in this study.
All study participants will be subjected to complete ophthalmic examination including slit-lamp and fundus examinations. Detailed medical history will be taken.
- Conditions
- Cataract
- Being tested
- genotyping assay by real-time PCR, ELISA
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotyping assay by real-time PCRGenetic
genotyping assay of MMP-2 gene with the real-time polymerase chain reaction
ELISADiagnostic test
. IL-6 level in serum will be analyzed by ELISA assay kit.
| Study group | Role | What they receive |
|---|---|---|
| control group (GroupA) | normal healthy non-cataractous volunteers aged ≥21 years Receives: Genetic: genotyping assay by real-time PCR; Diagnostic Test: ELISA | |
| Group B (experimental group 1) | cataractous patients aged >50 years and diagnosed with senile cataract. Receives: Genetic: genotyping assay by real-time PCR; Diagnostic Test: ELISA | |
| Group C (experimental group 2) | cataractous patients aged ≥21 to 50 years and diagnosed with secondary cataract Receives: Genetic: genotyping assay by real-time PCR; Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-2 gene (rs243865) polymorphism in cataract patients and healthy controls
Matrix Metalloproteinase-2 Gene Polymorphism using real-time PCR
Measured: 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.
measure serum levels of IL-6 by ELISA
Measured: 1 year maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jul 2023
- Primary completion30 Jan 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Sayed Hawwary Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670834
- Sponsor's protocol ID
- Soh-Med-22-12-06
- Status last verified
- Jul 2024
- First submitted
- 15 Dec 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31081067
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Matrix Metalloproteinase-2 Gene Polymorphism rs243865 and Susceptibility to Cataract Development
- ClinicalTrials.gov ID
- NCT05670834
- Acronym / sponsor ID
- Soh-Med-22-12-06
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cataract is a leading cause of blindness worldwide and is more common in low socioeconomic states and developing countries. According to the WHO, among 3 million visually impaired and 1 million blind persons in Egypt, about 60% have cataract.
The lens undergoes several morphological, biochemical, and physical changes with age which are causal for the formation of age-related cataract.
Oxidative stress can directly influence the solubility of the lens proteins, which increases the lens's opacity.
some studies suggest that inflammatory response may be involved in the occurrence of catarac. and that the pathophysiology is largely attributed to peptide mediators, such as transforming growth factor-beta (TGF-β), epidermal growth factor (EGF) and matrix metalloproteinases (MMPs), with the inhibition of these and other related molecules showing promising results.
Matrix metalloproteinases (MMPs) are a kind of calcium-zinc ion-dependent proteolytic enzyme involved in a variety of cellular processes. MMPs are well known for their ability to degrade the extracellular matrix (ECM) and are involved in several intracellular mechanisms from cell differentiation, proliferation, and angiogenesis to apoptosis.
Several studies' results suggest that the rs243865 (16q13-q21) polymorphism in the promoter region of the metalloproteinase-2 (MMP-2) gene is associated with ophthalmological disorders such as age-related macular degeneration. A recent study suggested that the MMP-2 rs243865 (C/T) polymorphism is associated with an increased risk of cataract.
The expression and activation of MMP-2 can be regulated by environmental influences from surrounding stroma, such as cytokines. some studies suggest that IL6 upregulates the expression of MMPs including MMP-2.
IL-6 is a soluble mediator with a pleiotropic effect on inflammation, immune response, and hematopoiesis. high levels of Il-6 in cataract patients may support the inflammatory response theory of disease development.
this study will follow the tenets of the Declaration of Helsinki. All study participants will sign informed written consent before enrolment in this study.
All study participants will be subjected to complete ophthalmic examination including slit-lamp and fundus examinations. Detailed medical history will be taken.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group (GroupA) | – | Genetic: genotyping assay by real-time PCR, Diagnostic Test: ELISAnormal healthy non-cataractous volunteers aged ≥21 years |
| Group B (experimental group 1) | – | Genetic: genotyping assay by real-time PCR, Diagnostic Test: ELISAcataractous patients aged >50 years and diagnosed with senile cataract. |
| Group C (experimental group 2) | – | Genetic: genotyping assay by real-time PCR, Diagnostic Test: ELISAcataractous patients aged ≥21 to 50 years and diagnosed with secondary cataract |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- cataractous patients in Department of ophthalmology in Sohag University Hospitals and healthy controls of matched age and sex
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- concomitant eye pathology or inflammation, systemic diseases and previous eye or systemic surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genotyping assay by real-time PCRgenotyping assay of MMP-2 gene with the real-time polymerase chain reaction | Genetic | Group B (experimental group 1), Group C (experimental group 2), control group (GroupA) |
| ELISA. IL-6 level in serum will be analyzed by ELISA assay kit. | Diagnostic test | Group B (experimental group 1), Group C (experimental group 2), control group (GroupA) |
Primary outcome
MMP-2 gene (rs243865) polymorphism in cataract patients and healthy controls
Time frame: 1 year maximum
Matrix Metalloproteinase-2 Gene Polymorphism using real-time PCR
1 secondary outcome
compare between cataract patients and healthy controls by measuring the serum IL-6 concentration to evaluate its relationship with disease.
Time frame: 1 year maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 31081067Dong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP-2 gene (rs243865) polymorphism in cataract patients and healthy controls (time frame: 1 year maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05670834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.