Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients

January 4, 2016 updated by: Lai Yin Peng, MD, University of Malaya

The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery

The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%.

To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
        • University of Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diabetic patient group

  1. Type 2 diabetes mellitus with no diabetic retinopathy
  2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
  3. Listed for phacoemulsification cataract surgery

Non diabetic patient group

  1. No history of diabetes
  2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
  3. Listed for phacoemulsification cataract surgery

Exclusion Criteria:

  1. Smoker
  2. Presence of immune disease, local or systemic inflammation
  3. Presence of retinal diseases, glaucoma
  4. Previous surgical procedure on the eye
  5. Intra-operative complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetes mellitus patients
Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
Drug: Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Other Names:
  • Acuvail
No Intervention: Diabetes mellitus control patients
Topical refresh plus four times a day for 3 days prior to cataract surgery
Active Comparator: Non diabetic patients
Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
Drug: Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Other Names:
  • Acuvail
No Intervention: Non diabetic control patients
Topical refresh plus four times a day for 3 days prior to cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays
Time Frame: 9 months
Aqueous samples were analyzed at the same after complete samples collection.
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Yin Peng Lai, MOphthal, University of Malaya
  • Study Chair: Mohammadreza Peyman, Mophthal, University of Malaya
  • Study Director: Tajunisah Iqbal, FRCS Ophth, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 12, 2015

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20148-494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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