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

Primary Purpose

Cystoid Macular Edema After Phacoemulsification

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
using of Ketorolac Tromethamine Eye Drop
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystoid Macular Edema After Phacoemulsification

Eligibility Criteria

20 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

installation of Ketorolac Tromethamine Eye Drop

not receiving placebo

Arm Description

Outcomes

Primary Outcome Measures

Best Corrected visual acuity
Snellen visual acuity chart

Secondary Outcome Measures

retinal and choroidal thickness
enhanced depth imaging optical coherence tomography (EDI-OCT)

Full Information

First Posted
April 10, 2018
Last Updated
May 29, 2018
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03551808
Brief Title
Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
Official Title
Prophylactic Effect of Ketorolac Tromethamine on the Cystoid Macular Edema After Phacoemulsification in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystoid Macular Edema After Phacoemulsification

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
installation of Ketorolac Tromethamine Eye Drop
Arm Type
Active Comparator
Arm Title
not receiving placebo
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
using of Ketorolac Tromethamine Eye Drop
Intervention Description
using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery
Primary Outcome Measure Information:
Title
Best Corrected visual acuity
Description
Snellen visual acuity chart
Time Frame
24 weeks after the surgery
Secondary Outcome Measure Information:
Title
retinal and choroidal thickness
Description
enhanced depth imaging optical coherence tomography (EDI-OCT)
Time Frame
24 weeks after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hossien Mohammad Rabie, MD
Phone
9822591616
Email
labbafi@hotmail.com
Facility Information:
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossien Mohammad Rabie, MD
Phone
9822591616
Email
labbafi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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