Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Protein Profile of Immunoregulatory Factors in Diabetic Cataract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832311
• Other study ID #: 108-1080229-0142
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2013
• Last updated: April 10, 2013
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cataract
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Ketorolac
Patients (both non-diabetic and diabetic) were randomized into subgroups receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac 0.5%, dosed 4 times a day, starting 3-7 days before surgery and ending 4-5 weeks after surgery respectively, and into subgroups not receiving NSAID.

Locations

Country	Name	City	State
Croatia	Department of Ophtalmology, General Hospital "Dr. J. Bencevic"	Slavonski brod	Brodsko-posavska zupanija
Croatia	Department of Physiology and Immunology, University of Zagreb School of Medicine	Zagreb	Grad Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level of interleukin-10		2 hours before the surgery	No
Primary	serum level of monocyte chemotactic protein-1		2 hours before the surgery	No
Primary	serum level of interleukin-17		2 hours before the surgery	No
Primary	serum level of Fas ligand		2 hours before the surgery	No
Primary	serum level of vascular endothelial growth factor		2 hours before the surgery	No
Primary	level of interleukin-10 in aqueous humor		intraoperatively, at the start of the surgical procedure	No
Primary	level of monocyte chemotactic protein-1 in aqueous humor		intraoperatively, at the start of the surgical procedure	No
Primary	level of interleukin-17 in aqueous humor		intraoperatively, at the start of the surgical procedure	No
Primary	level of Fas ligand in aqueous humor		intraoperatively, at the start of the surgical procedure	No
Primary	level of vascular endothelial growth factor in aqueous humor		intraoperatively, at the start of the surgical procedure	No
Secondary	degree of corneal edema		preoperatively - 2 hours before the surgery	No
Secondary	degree of corneal edema		postoperatively - day 1	No
Secondary	degree of corneal edema		postoperatively - day 8	No
Secondary	degree of corneal edema		postoperatively - week 3	No
Secondary	degree of corneal edema		postoperatively - month 3	No