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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystoid Macular Edema After Phacoemulsification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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installation of Ketorolac Tromethamine Eye Drop

Group Type ACTIVE_COMPARATOR

using of Ketorolac Tromethamine Eye Drop

Intervention Type DRUG

using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery

not receiving placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes