Cystoid Macular Edema Following Cataract Surgery, Bilateral Clinical Trial
Official title:
A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.
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.
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention