Trial | NCT01832311  Report issue

Official Title

Protein Profile of Immunoregulatory Factors in Diabetic Cataract

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ketorolac ...

  • Study Participants

    61
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.
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.
Study Started
Jan 31
2009
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2012
Last Update
Apr 16
2013
Estimate

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.

  • Other names: Toradol, Acular, Sprix

senile cataract with NSAID Experimental

15 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.

diabetic cataract with NSAID Experimental

17 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac.

senile cataract without NSAID No Intervention

17 non-diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac.

diabetic cataract without NSAID No Intervention

12 diabetic patients undergoing phacoemulsification combined with IOL implantation. Subgroup not receiving topical ketorolac.

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)
No Results Posted