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Completed

NCT Number: NCT02646072

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

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.

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Key information

Conditions

Cystoid Macular Edema, Postoperative Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Degeneration Macular Edema Metabolic Diseases Nutritional and Metabolic Diseases Retinal Degeneration Retinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Malaya

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac tromethamine ophthalmic solution 0.45%

Drug

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

Other names: Acuvail

Primary outcomes

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

    Time frame: 9 months

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

Secondary outcomes

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

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2016
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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