CataractDEL-1 and IL-1NCT06995131
Evaluation of Aqueous Humor DEL-1 and IL-17 Levels in Diabetic Cataract Patients
An observational study of Cataract, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Observational Study Procedure
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 15 Oct 2025
- Phase
- Observational
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients scheduled for cataract surgery * Diabetic cataract patients (diagnosed with Type 2 Diabetes and HbA1c measured) * Nondiabetic cataract patients (without a diagnosis of diabetes)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak University Training and Research Hospital
Uşak, 64200
About this study
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.
Read the detailed description
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
- Cataract
- Being tested
- Observational Study Procedure
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study ProcedureOther
No intervention was administered. This was a prospective observational case-control study. Participants underwent routine ophthalmologic examinations and aqueous humor sampling during cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Cataract Group | Patients with type 2 diabetes and cataract without diabetic retinopathy. Receives: Other: Observational Study Procedure | |
| Control Group | Non-diabetic patients undergoing cataract surgery. Receives: Other: Observational Study Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEL-1 and IL-17 Levels
Aqueous humor DEL-1 and IL-17 concentrations were measured quantitatively using ELISA and are reported in pg/mL.
Measured: During cataract surgery, at the time of aqueous humor collection
Secondary outcomes (4)
HbA1c
Blood HbA1c concentrations were measured in all study participants and are reported as percentage (%).
Measured: Preoperative, before cataract surgery
Association Between Aqueous Humor DEL-1 and IL-17 Levels
Spearman correlation analyses were performed to evaluate the association between aqueous humor DEL-1 and IL-17 concentrations separately for the Diabetic Cataract Group and the Control Group. Spearman's correlation coefficients (rho) are reported for each study arm.
Measured: During cataract surgery, at the time of aqueous humor collection
Association of Biomarker Levels With HbA1c
Spearman correlation analyses were performed separately for the Diabetic Cataract Group and the Control Group to evaluate the associations between aqueous humor DEL-1 and IL-17 concentrations and HbA1c. Spearman's correlation coefficients (rho) are reported for each study arm.
Measured: Perioperative, based on the most recent HbA1c measurement available before cataract surgery
Association Between Demographic Variables and DEL-1/IL-17 Levels
Spearman correlation analyses were performed to evaluate the associations between demographic variables and aqueous humor DEL-1 and IL-17 concentrations separately for the Diabetic Cataract Group and the Control Group. Correlation coefficients are reported for each study arm.
Measured: During cataract surgery, at the time of aqueous humor collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 May 2025
- Primary completion1 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzan Dogruya, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995131
- Sponsor's protocol ID
- DEL 1- IL 17
- Acronym
- DEL-1 and IL-1
- Status last verified
- Jul 2026
- First submitted
- 20 May 2025
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) obtained in this study will be shared anonymised with requesting researchers for reasonable research purposes and in accordance with ethical rules.
Publications
Dogruya S, Sagkan RI. Levels of DEL-1 and IL-17 in the aqueous humor of cataract patients with diabetes without diabetic retinopathy. Int Ophthalmol. 2026 Jun 25;46(1):270. doi: 10.1007/s10792-026-04142-3.
PubMed 42347979