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

University of Malaya80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cystoid Macular Edema, Postoperative Diabetes Mellitus

Interventions

Ketorolac tromethamine ophthalmic solution 0.45%DRUG

Indicated for the treatment of pain and inflammation following cataract surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays

Aqueous samples were analyzed at the same after complete samples collection.

Time frame: 9 months

Secondary Outcomes

Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography

Time frame: 9 months

Data from ClinicalTrials.gov

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