Clinical trial NCT02646072: Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystoid Macular Edema, Postoperative
Diabetes Mellitus
Keywords: diabetes mellitus
aqueous humor
inflammatory cytokines
cystoid macular edema, postoperative
nonsteroidal anti-inflammatory drugs
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of aqueous inflammatory cytokines post treatment as assessed using Bio-plex Pro Assays
timeFrame: 9 months
Secondary outcomes:
measure: Changes from baseline in central subfield retinal thickness as assessed by optical coherence tomography
timeFrame: 9 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Yin Peng Lai, MOphthal
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Mohammadreza Peyman, Mophthal
role: STUDY_CHAIR
affiliation: University of Malaya
name: Tajunisah Iqbal, FRCS Ophth
role: STUDY_DIRECTOR
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