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

Sponsor
University of Malaya (Other)
Overall Status
Completed
CT.gov ID
NCT02646072
Collaborator
(none)
80
1
4
10
8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ketorolac tromethamine ophthalmic solution 0.45%
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays [9 months]

      Aqueous samples were analyzed at the same after complete samples collection.

    Secondary Outcome Measures

    1. Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography [9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Malaya Kuala Lumpur Wilayah Persekutuan Malaysia 50603

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lai Yin Peng, MD, Principal Investigator, University of Malaya
    ClinicalTrials.gov Identifier:
    NCT02646072
    Other Study ID Numbers:
    • 20148-494
    First Posted:
    Jan 5, 2016
    Last Update Posted:
    Jan 5, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Lai Yin Peng, MD, Principal Investigator, University of Malaya
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2016