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

NCT03551808 | Unknown Phase 2

• 1 other identifier: 96316
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystoid Macular Edema After Phacoemulsification

Outcome Measures

Primary Outcomes (1)

• Best Corrected visual acuity

  Snellen visual acuity chart

  24 weeks after the surgery

Secondary Outcomes (1)

• retinal and choroidal thickness

  24 weeks after the surgery

Study Arms (2)

installation of Ketorolac Tromethamine Eye Drop

ACTIVE COMPARATOR

Drug: using of Ketorolac Tromethamine Eye Drop

not receiving placebo

NO INTERVENTION

Interventions

using of Ketorolac Tromethamine Eye Drop 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

installation of Ketorolac Tromethamine Eye Drop

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Unknown Facility

Tehran, Iran

RECRUITING

Related Publications (1)

• Mohammad-Rabei H, Sabbaghi H, Emamverdi M, Karimi S, Ramezani A, Nikkhah H, Kheiri B, Yaseri M, Sheibani K, Bahreini R. The effect of topical ketorolac tromethamine on macular thickening after phacoemulsification in diabetic patients. BMC Ophthalmol. 2023 Jul 14;23(1):320. doi: 10.1186/s12886-023-03077-y.

  PMID: 37452330 DERIVED

Central Study Contacts

Hossien Mohammad Rabie, MD

CONTACT

9822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 11, 2018
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-04

Locations

IR (1)