Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus; Cystoid Macular Edema, Postoperative
• Interventions: Drug: Ketorolac tromethamine ophthalmic solution 0.45%

• Registration Number: NCT02646072
• Lead Sponsor: University of Malaya

Brief Summary

The purpose of this study is to determine whether there is a relationship between inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment of topical ketorolac for patients undergoing cataract surgery.

Detailed Description

To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients treated with preoperative topical ketorolac tromethamine 0.45%.

To compare the macular thickness changes in diabetic and non diabetic patients treated with preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory cytokines.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Study First Submitted: 2015-12-12
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-04
• Last Update Submitted: 2016-01-04
• Study First Posted: 2016-01-05
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Diabetic patient group

1. Type 2 diabetes mellitus with no diabetic retinopathy
2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
3. Listed for phacoemulsification cataract surgery

Non diabetic patient group

1. No history of diabetes
2. If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months
3. Listed for phacoemulsification cataract surgery

Exclusion Criteria

1. Smoker
2. Presence of immune disease, local or systemic inflammation
3. Presence of retinal diseases, glaucoma
4. Previous surgical procedure on the eye
5. Intra-operative complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes mellitus patients	Ketorolac tromethamine ophthalmic solution 0.45%	Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery
Non diabetic patients	Ketorolac tromethamine ophthalmic solution 0.45%	Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Primary Outcome Measures

Name	Time	Method
Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays	9 months	Aqueous samples were analyzed at the same after complete samples collection.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography	9 months

Trial Locations

Locations (1)

University of Malaya; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia