Cystoid Macular Edema Following Cataract Surgery, Bilateral — Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery
Citation(s)
Gass JD, Norton EW Cystoid macular edema and papilledema following cataract extraction. A fluorescein fundoscopic and angiographic study. Arch Ophthalmol. 1966 Nov;76(5):646-61.
Kim A, Stark WJ Are topical NSAIDs needed for routine cataract surgery? Am J Ophthalmol. 2008 Oct;146(4):483-5. doi: 10.1016/j.ajo.2008.07.027.
Miyake K, Ibaraki N Prostaglandins and cystoid macular edema. Surv Ophthalmol. 2002 Aug;47 Suppl 1:S203-18. Review.
Miyake K, Ota I, Miyake G, Numaga J Nepafenac 0.1% versus fluorometholone 0.1% for preventing cystoid macular edema after cataract surgery. J Cataract Refract Surg. 2011 Sep;37(9):1581-8. doi: 10.1016/j.jcrs.2011.03.052.
Miyake K Prevention of cystoid macular edema after lens extraction by topical indomethacin (I). A preliminary report. Albrecht Von Graefes Arch Klin Exp Ophthalmol. 1977 Aug 8;203(2):81-8.
Rossetti L, Chaudhuri J, Dickersin K Medical prophylaxis and treatment of cystoid macular edema after cataract surgery. The results of a meta-analysis. Ophthalmology. 1998 Mar;105(3):397-405.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
