NCT01832311

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

Enrollment Period

2.9 years

First QC Date

April 5, 2013

Last Update Submit

April 10, 2013

Conditions

CataractType 2 Diabetes Mellitus

Keywords

type 2 diabetes mellituscataractcytokineschemokinesaqueous humor

Outcome Measures

Primary Outcomes (10)

  • serum level of interleukin-10

    2 hours before the surgery

  • serum level of monocyte chemotactic protein-1

    2 hours before the surgery

  • serum level of interleukin-17

    2 hours before the surgery

  • serum level of Fas ligand

    2 hours before the surgery

  • serum level of vascular endothelial growth factor

    2 hours before the surgery

  • level of interleukin-10 in aqueous humor

    intraoperatively, at the start of the surgical procedure

  • level of monocyte chemotactic protein-1 in aqueous humor

    intraoperatively, at the start of the surgical procedure

  • level of interleukin-17 in aqueous humor

    intraoperatively, at the start of the surgical procedure

  • level of Fas ligand in aqueous humor

    intraoperatively, at the start of the surgical procedure

  • level of vascular endothelial growth factor in aqueous humor

    intraoperatively, at the start of the surgical procedure

Secondary Outcomes (5)

  • degree of corneal edema

    preoperatively - 2 hours before the surgery

  • degree of corneal edema

    postoperatively - day 1

  • degree of corneal edema

    postoperatively - day 8

  • degree of corneal edema

    postoperatively - week 3

  • degree of corneal edema

    postoperatively - month 3

Study Arms (4)

senile cataract with NSAID

EXPERIMENTAL

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

Drug: Ketorolac

diabetic cataract with NSAID

EXPERIMENTAL

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

Drug: 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.

Interventions

KetorolacDRUG

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.

Also known as: Toradol, Acular, Sprix
diabetic cataract with NSAIDsenile cataract with NSAID

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Ophtalmology, General Hospital "Dr. J. Bencevic"

Slavonski Brod, Brod-Posavina County, 35000, Croatia

Location

Department of Physiology and Immunology, University of Zagreb School of Medicine

Zagreb, City of Zagreb, 10000, Croatia

Location

Related Publications (39)

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    PMID: 1895223BACKGROUND

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MeSH Terms

Conditions

CataractDiabetes Mellitus, Type 2

Interventions

KetorolacKetorolac Tromethamine

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Danka Grcevic, prof.,MD,PhD

    University of Zagreb

    PRINCIPAL INVESTIGATOR

  • Sanja Mitrovic, MD

    Department of Ophthalmology, General Hospital "Dr. J. Bencevic"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Danka Grcevic, MD, PhD

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 16, 2013

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

CR(2)