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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Preoperative Topical Ketorolac 0.45% on Aqueous Cytokine Levels and Macular Thickness in Diabetic and Non Diabetic Patients Undergoing Cataract Surgery

Conditions
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Cystoid Macular Edema, Postoperative, Diabetes Mellitus

Intervention / Treatment
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* Drug: Ketorolac tromethamine ophthalmic solution 0.45%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patient group Type 2 diabetes mellitus with no diabetic retinopathy If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months Listed for phacoemulsification cataract surgery Non diabetic patient group No history of diabetes If with co-morbid, controlled hypertension with no hypertensive crisis in recent six months Listed for phacoemulsification cataract surgery Exclusion Criteria: Smoker Presence of immune disease, local or systemic inflammation Presence of retinal diseases, glaucoma Previous surgical procedure on the eye Intra-operative complications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetes mellitus patients<br>Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery | Drug: Ketorolac tromethamine ophthalmic solution 0.45%<br>* Indicated for the treatment of pain and inflammation following cataract surgery.<br>* Other names: Acuvail;|
| No Intervention: Diabetes mellitus control patients<br>Topical refresh plus four times a day for 3 days prior to cataract surgery | |
| Active Comparator: Non diabetic patients<br>Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery | Drug: Ketorolac tromethamine ophthalmic solution 0.45%<br>* Indicated for the treatment of pain and inflammation following cataract surgery.<br>* Other names: Acuvail;|
| No Intervention: Non diabetic control patients<br>Topical refresh plus four times a day for 3 days prior to cataract surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, aqueous humor, inflammatory cytokines, cystoid macular edema, postoperative, nonsteroidal anti-inflammatory drugs