Clinical trial NCT01832311: Protein Profile of Immunoregulatory Factors in Diabetic Cataract
Official title: Protein Profile of Immunoregulatory Factors in Diabetic Cataract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
cataract
cytokines
chemokines
aqueous humor
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the levels of several immunoregulatory factors in serums and aqueous humor of type II diabetes cataract patients with those in senile non-diabetic cataract patients since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens surgery complications.

Detailed description: The study compared the levels of several immunoregulatory molecules (vascular endothelial growth factor (VEGF), monocyte chemotactic protein-1 (MCP-1), Fas Ligand (FasL), interleukin-10 (IL-10) and interleukin-17 (IL-17)) in serum and aqueous humor between type 2 diabetes mellitus patients, without clinically evident diabetic retinopathy or diabetic macular edema, and nondiabetic cataract patients.

Investigators also investigated whether concentrations of immunoregulatory molecules significantly correlated with intraoperative and postoperative parameters. Particularly, investigators focused on the development of corneal edema as one of the main causes of low visual acuity in the immediate postoperative period after intraocular lens implantation.

Since disturbed cytokine and growth factor microenvironment in diabetic eye may contribute to an increased frequency of intraoperative and postoperative intraocular lens (IOL) surgery complications, the findings may be relevant for the development of therapeutic strategies aimed to restore protein profile of immunoregulatory factors in parallel to cataract treatment.

Eligibility criteria: Inclusion Criteria:

* patients undergoing phacoemulsification combined with IOL implantation
* for diabetic group: duration of type 2 diabetes mellitus (T2DM) for 10 to 15 years
* for diabetic group: therapy with oral hypoglycemic agents for glycemic control
* no other ocular (retinal) or systemic diabetic complications of T2DM

Exclusion Criteria:

* patients who had cataract that could result from some other ocular condition, systemic disease (except T2DM for diabetic group) or trauma
* patients with immune disease, local or systemic inflammation which could affect cytokine concentration in serum or aqueous humor (AH)

Primary outcomes:
measure: serum level of interleukin-10
timeFrame: 2 hours before the surgery
measure: serum level of monocyte chemotactic protein-1
timeFrame: 2 hours before the surgery
measure: serum level of interleukin-17
timeFrame: 2 hours before the surgery
measure: serum level of Fas ligand
timeFrame: 2 hours before the surgery
measure: serum level of vascular endothelial growth factor
timeFrame: 2 hours before the surgery
measure: level of interleukin-10 in aqueous humor
timeFrame: intraoperatively, at the start of the surgical procedure
measure: level of monocyte chemotactic protein-1 in aqueous humor
timeFrame: intraoperatively, at the start of the surgical procedure
measure: level of interleukin-17 in aqueous humor
timeFrame: intraoperatively, at the start of the surgical procedure
measure: level of Fas ligand in aqueous humor
timeFrame: intraoperatively, at the start of the surgical procedure
measure: level of vascular endothelial growth factor in aqueous humor
timeFrame: intraoperatively, at the start of the surgical procedure
Secondary outcomes:
measure: degree of corneal edema
timeFrame: preoperatively - 2 hours before the surgery
measure: degree of corneal edema
timeFrame: postoperatively - day 1
measure: degree of corneal edema
timeFrame: postoperatively - day 8
measure: degree of corneal edema
timeFrame: postoperatively - week 3
measure: degree of corneal edema
timeFrame: postoperatively - month 3
Other outcomes:
Locations:
city: Slavonski brod
country: Croatia
facility: Department of Ophtalmology, General Hospital "Dr. J. Bencevic"
state: Brodsko-posavska zupanija
city: Zagreb
country: Croatia
facility: Department of Physiology and Immunology, University of Zagreb School of Medicine
state: Grad Zagreb
Study officials:
affiliation: University of Zagreb
name: Danka Grcevic, prof.,MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Ophthalmology, General Hospital "Dr. J. Bencevic"
name: Sanja Mitrovic, MD
role: PRINCIPAL_INVESTIGATOR
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