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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03551808
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 6

Study Details

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.

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

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2017
• Actual Primary Completion Date: Jun 1, 2017
• Anticipated Study Completion Date: Jun 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Best Corrected visual acuity [24 weeks after the surgery]

   Snellen visual acuity chart

Secondary Outcome Measures

1. retinal and choroidal thickness [24 weeks after the surgery]

   enhanced depth imaging optical coherence tomography (EDI-OCT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zahra Rabbani Khah, Clinical Professor, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03551808
• Other Study ID Numbers: 96316
• First Posted: Jun 11, 2018
• Last Update Posted: Jun 11, 2018
• Last Verified: Apr 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema; Edema; Ketorolac; Ketorolac Tromethamine; Ophthalmic Solutions

Study Results

No Results Posted as of Jun 11, 2018