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

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ClinicalTrials.gov Identifier: NCT02646072
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Lai Yin Peng, MD, University of Malaya

Tracking Information
First Submitted Date  ICMJE December 12, 2015
First Posted Date  ICMJE January 5, 2016
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients
Official Title  ICMJE The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cystoid Macular Edema, Postoperative
  • Diabetes Mellitus
Intervention  ICMJE Drug: Ketorolac tromethamine ophthalmic solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
Other Name: Acuvail
Study Arms  ICMJE
  • Active Comparator: Diabetes mellitus patients
    Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
    Intervention: Drug: Ketorolac tromethamine ophthalmic solution 0.45%
  • 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
    Intervention: Drug: Ketorolac tromethamine ophthalmic solution 0.45%
  • No Intervention: Non diabetic control patients
    Topical refresh plus four times a day for 3 days prior to cataract surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02646072
Other Study ID Numbers  ICMJE 20148-494
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lai Yin Peng, MD, University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Malaya
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP