Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Cystoid Macular Edema, Postoperative Diabetes Mellitus 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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 Name: 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 Name: Acuvail

No Intervention: Non diabetic control patients
Topical refresh plus four times a day for 3 days prior to cataract surgery



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography [ Time Frame: 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646072


Locations
Layout table for location information
Malaysia
University of Malaya
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
Sponsors and Collaborators
University of Malaya
Investigators
Layout table for investigator information
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:

Layout table for additonal information
Responsible Party: Lai Yin Peng, MD, Principal Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT02646072     History of Changes
Other Study ID Numbers: 20148-494
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lai Yin Peng, MD, University of Malaya:
diabetes mellitus
aqueous humor
inflammatory cytokines
cystoid macular edema, postoperative
nonsteroidal anti-inflammatory drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Ketorolac
Ketorolac Tromethamine
Cataract
Macular Edema
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action