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Completed

NCT Number: NCT01832311

Protein Profile of Immunoregulatory Factors in Diabetic Cataract

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophtalmology, General Hospital "Dr. J. Bencevic", Slavonski Brod, Brod-Posavina County, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ketorolac

Drug

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

Primary outcomes

  1. serum level of interleukin-10

    Time frame: 2 hours before the surgery

  2. serum level of monocyte chemotactic protein-1

    Time frame: 2 hours before the surgery

  3. serum level of interleukin-17

    Time frame: 2 hours before the surgery

  4. serum level of Fas ligand

    Time frame: 2 hours before the surgery

  5. serum level of vascular endothelial growth factor

    Time frame: 2 hours before the surgery

  6. level of interleukin-10 in aqueous humor

    Time frame: intraoperatively, at the start of the surgical procedure

  7. level of monocyte chemotactic protein-1 in aqueous humor

    Time frame: intraoperatively, at the start of the surgical procedure

  8. level of interleukin-17 in aqueous humor

    Time frame: intraoperatively, at the start of the surgical procedure

  9. level of Fas ligand in aqueous humor

    Time frame: intraoperatively, at the start of the surgical procedure

  10. level of vascular endothelial growth factor in aqueous humor

    Time frame: intraoperatively, at the start of the surgical procedure

Secondary outcomes

  1. degree of corneal edema

    Time frame: preoperatively - 2 hours before the surgery

  2. degree of corneal edema

    Time frame: postoperatively - day 1

  3. degree of corneal edema

    Time frame: postoperatively - day 8

  4. degree of corneal edema

    Time frame: postoperatively - week 3

  5. degree of corneal edema

    Time frame: postoperatively - month 3

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Apr 16, 2013
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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