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Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT03551808
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Brief Summary:
The aim of the study is determining the prophylactic effect of ketorolac tromethamine drop 0.5% eye drop on the functional and anatomical ocular characteristics of the diabetic patients after the phacoemulsification surgery. Cystoid macular edema (CME) is a ocular disease which the retinal thickness is increased by 30 % incidence at least or the visual acuity is decreased to 20/40 according to clinical definition. Ketorolac tromethamine is an non steroidal anti inflammatory medication which is used for treatment and Prophylactic for CME. Teh aim of this study is prophylactic effect of ketorolac tromethamine on choroidal and retinal thickness after Phacoemulsification in Diabetic Patients. In this randomized clinical trial, 102 eyes of 102 diabetic patients were included. All patients were undergone phacoemulsification surgery at Torfeh Eye Hospital between September 2015 and January 2017. To evaluate the prophylactic effect of ketorolac tromethamine topical eye drop, all cases were asked to apply it one day before the s:surgery in each 8 hours and continue it for 4 weeks after the surgery. Controls were not received placebo. All study population were examined using Snellen visual acuity chart, enhanced depth imaging optical coherence tomography (EDI-OCT). All patients were followed at 6, 12 and 24 weeks after the cataract surgery.

Condition or disease Intervention/treatment Phase
Cystoid Macular Edema After Phacoemulsification Drug: using of Ketorolac Tromethamine Eye Drop Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: installation of Ketorolac Tromethamine Eye Drop Drug: using of Ketorolac Tromethamine Eye Drop
using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery

No Intervention: not receiving placebo



Primary Outcome Measures :
  1. Best Corrected visual acuity [ Time Frame: 24 weeks after the surgery ]
    Snellen visual acuity chart


Secondary Outcome Measures :
  1. retinal and choroidal thickness [ Time Frame: 24 weeks after the surgery ]
    enhanced depth imaging optical coherence tomography (EDI-OCT)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diabetic patients (type II) with cataract
  • Eligible patients at age range of 20 to 95 years old

Exclusion Criteria:

  • Cases with a diabetic macular edema
  • proliferative diabetic retinopathy
  • history of intravitreal injection of bevacizumab and macular photocoagulation prior three months to the cataract surgery
  • glaucoma
  • refractive errors of more than ±6 diopters
  • history of previous ocular surgery
  • ocular pathological disorders
  • history of systemic diseases
  • history of medications which have a side effect on the retinal thickness
  • patients with a follow up of less than 6 months
  • individuals with any intraoperative complications will be excluded from this study.

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): NCT03551808


Contacts
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Contact: Hossien Mohammad Rabie, MD 9822591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Recruiting
Tehran, Iran, Islamic Republic of
Contact: Hossien Mohammad Rabie, MD    9822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

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Responsible Party: Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03551808     History of Changes
Other Study ID Numbers: 96316
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye 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