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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02646072

Enrollment

Registered

2016-01-05

Start date

2014-08-31

Completion date

2015-06-30

Last updated

2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystoid Macular Edema, Postoperative, Diabetes Mellitus

Keywords

diabetes mellitus, aqueous humor, inflammatory cytokines, cystoid macular edema, postoperative, nonsteroidal anti-inflammatory drugs

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.

Interventions

DRUGKetorolac tromethamine ophthalmic solution 0.45%

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026