Evaluation of Aqueous Humor DEL-1 and IL-17 Levels in Diabetic Cataract Patients

NCT ID: NCT06995131

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

By comparing DEL-1 and IL-17 levels in the aqueous humor of diabetic cataract patients with the aqueous humor of non-diabetic patients, we aim to understand the biochemical effects of diabetes-related inflammatory processes in the eye.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Developmental Endothelial Locus-1 (DEL-1) is a molecule related to endothelial cells and is a protein involved in intercellular interactions. It is generally associated with the development and function of endothelial cells lining the inner surface of the vessel. It plays an important role in the regulation of inflammation, the development of vessels and the organization of endothelial cells. It has also been shown to be associated with some types of cancer. It may also be effective in tissue regeneration and healing of injuries.

IL-17 (Interleukin-17) is a group of cytokines that play an important role in the immune system. There are several subtypes of IL-17, the best known and most researched being IL-17A. It regulates the body's immune response to certain infections. It is an important cytokine that initiates and supports the inflammation process. IL-17 plays an important role in the pathogenesis of various autoimmune and inflammatory diseases.

DEL-1 and IL-17 are two different molecules that act on inflammation and immune responses. DEL-1 helps regulate inflammation by protecting vascular health, while IL-17 can accelerate the course of diseases by increasing inflammation.

Diabetes is a systemic disease associated with oxidative stress and chronic inflammation. Retinopathy, cataract and glaucoma diseases develop due to diabetes. DEL-1 is a protein involved in the maintenance of vascular homeostasis and regulation of inflammation. Since diabetic patients have chronic inflammation and microvascular dysfunction, changes in DEL-1 levels may provide important clues to the pathophysiology

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Group (n=30) Non-diabetic Group

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors
During the statistical analysis, the data analyst can analyze only "Group A" and "Group B" without knowing the group names. After the results are obtained, the groups are opened.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetic cataract patients

Collection of aqueous humor during cataract surgery in non-diabetic patients and study of DEL1 and IL 17

Group Type EXPERIMENTAL

Del 1

Intervention Type DIAGNOSTIC_TEST

During cataract surgery, approximately 0.1-0.2 mL of aqueous humor will be sampled with a sterile 27 gauge syringe before viscoelastic is introduced into the anterior chamber. DEL 1 will be analyzed by ELISA

IL 17

Intervention Type DIAGNOSTIC_TEST

During cataract surgery, approximately 0.1-0.2 mL of aqueous humor will be sampled with a sterile 27 gauge syringe before viscoelastic is introduced into the anterior chamber. IL 17 levels will be analyzed by ELISA

Non-diabetic cataract patients

Collection of aqueous humor during cataract surgery in non-diabetic patients and study of DEL1 and IL 17

Group Type SHAM_COMPARATOR

Del 1

Intervention Type DIAGNOSTIC_TEST

During cataract surgery, approximately 0.1-0.2 mL of aqueous humor will be sampled with a sterile 27 gauge syringe before viscoelastic is introduced into the anterior chamber. DEL 1 will be analyzed by ELISA

IL 17

Intervention Type DIAGNOSTIC_TEST

During cataract surgery, approximately 0.1-0.2 mL of aqueous humor will be sampled with a sterile 27 gauge syringe before viscoelastic is introduced into the anterior chamber. IL 17 levels will be analyzed by ELISA

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Del 1

During cataract surgery, approximately 0.1-0.2 mL of aqueous humor will be sampled with a sterile 27 gauge syringe before viscoelastic is introduced into the anterior chamber. DEL 1 will be analyzed by ELISA

Intervention Type DIAGNOSTIC_TEST

IL 17

During cataract surgery, approximately 0.1-0.2 mL of aqueous humor will be sampled with a sterile 27 gauge syringe before viscoelastic is introduced into the anterior chamber. IL 17 levels will be analyzed by ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cataract diagnosed and surgery planned
* Patients without any other ocular pathology other than cataract.
* Type 2 DM for at least 5 years in the diabetic group

Exclusion Criteria

* Patients with previous intraocular surgery
* Those with inflammatory eye diseases (e.g. uveitis)
* Those with autoimmune diseases or systemic inflammatory diseases
* Those receiving local or systemic steroid therapy
* Those with severe systemic disease (e.g. advanced renal failure, malignancy)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uşak University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Suzan Dogruya

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uşak Training and Research Hospital

Uşak, Uşak, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Suzan Dogruya

Role: CONTACT

+905322270732

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Suzan Doğruya

Role: primary

05322270732

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DEL 1- IL 17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endothelial Cell Loss After Cataract Surgery
NCT00932191 TERMINATED PHASE2/PHASE3