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

University of Malaya

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus; Cystoid Macular Edema, Postoperative

Treatments: Drug: Ketorolac tromethamine ophthalmic solution 0.45%

Study type: Interventional

Funder types: Other

Identifiers

NCT02646072

20148-494

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Diabetes mellitus patients

Active Comparator group

Description:

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Treatment:

Drug: Ketorolac tromethamine ophthalmic solution 0.45%

Diabetes mellitus control patients

No Intervention group

Description:

Topical refresh plus four times a day for 3 days prior to cataract surgery

Non diabetic patients

Active Comparator group

Description:

Ketorolac tromethamine ophthalmic solution 0.45% four times a day for 3 days prior to cataract surgery

Treatment:

Drug: Ketorolac tromethamine ophthalmic solution 0.45%

Non diabetic control patients

No Intervention group

Description:

Topical refresh plus four times a day for 3 days prior to cataract surgery