Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery

Phase 4

Completed

• Conditions: Cystoid Macular Edema Following Cataract Surgery, Bilateral
• Interventions: Drug: Ketorolac Tromethamine

• Registration Number: NCT01542190
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

The purpose of this study is to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.

Patients scheduled to undergo phacoemulsification will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group) for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema.

Detailed Description

Purpose:

To compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery.

Methods:

This will be a masked single-center, randomized clinical study comprising 80 patients undergoing phacoemulsification cataract surgery. Patients scheduled to undergo phacoemulsification and with no recognized cystoid macular edema (CME) risks (diabetic retinopathy, retinal vascular disease or macular abnormality) will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group;n=40) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group;n=40) for three days preoperatively and four weeks postoperatively. In both groups topical gatifloxacin will be administered to the treated eye QID, starting three days before surgery and continuing for seven days. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema. Other included outcomes will be best corrected visual acuity (BCVA), intraocular pressure (IOP), CME incidence, retinal thickness as measured by spectral-domain optical coherence tomography (OCT).

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-02
• Primary Completion: 2012-12
• Study Completion: 2013-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subjects with nuclear cataract, density 1 and 2 classified by LOCS II, scheduled to undergo phacoemulsification cataract surgery.

Exclusion Criteria

• Patients with:

  • Diabetes,
  • Hypertension,
  • uveitis,
  • macular disease,
  • congenital ocular abnormalities,
  • cataract density 0 and 3 by LOCS II,
  • pseudoexfoliation syndrome.

Patients under treatment with nonsteroidal antinflammatory drugs or topical eye drops were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketorolac tromethamine	Ketorolac Tromethamine	-
Dextrano 70 / Hypromellose	Ketorolac Tromethamine	-

Primary Outcome Measures

Name	Time	Method
cystoid macular edema	1 month	Angiography (Miyake's criteria)

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity	1 month	ETDRS.

Trial Locations

Locations (1)

Unicamp; 🇧🇷 Campinas, Sao Paulo, Brazil