Phacoemulsification
Conditions
Interventions
Patients in the cataract surgery postoperative will be randomized by random electronic drawing performed by a masked researcher into 4 protocol groups: Group 1: antibiotic eye drops 6/6h for 7 days an
Group 2: 6/6h antibiotic eye drops for 8 days and 1% prednisolone acetate corticoid eyedrops starting at 4/4h and tapering (1 dose reduction every 7 days) for 4 weeks
Group 3: 6/6h antibiotic eye drops for 8 days and loteprednol etabonate corticosteroid eye drops starting at 4/4h and tapering (1 dose reduction every 7 days) for 4 weeks
Group 4: 6/6h antibiotic eye drops for 8 days and 1% prednisolone acetate corticoid eye drops every 4h for 10 days. 35 patients in each group. An unmasked investigator will be responsible for randomiz
Sponsors
Instituto para o Desenvolvimento da Educação Ltda-IPADE/Faculdade
Universitary Center Christus (Centro Universitário Christus - Unichristus)
Instituto Cearense de Oftalmologia (ICO)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with cataracts; Over 18 years old; Patients from Instituto Cearense de Oftalmologia cataracts department; Patients who do not have other eye conditions that cause eye inflammation, increased intraocular pressure, decreased visual acuity and macular edema, including diabetic retinopathy; Patients who accepted to participate the study signed the informed consent form.
Exclusion criteria
Exclusion criteria: Ocular affections which cause inflammation, elevated intraocular pressure, reduced vision acuity and macular edema; Allergy to corticosteroids; Any condition that could interfere to the correct use of the eye drops, including patient's social and/or economic situation; Use of any eye drops, except lubricants Ocular or systemic use of Non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressives or anti-histaminics 2 days before to 21 days after the surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find out a corticosteroid protocol with the best cost-effectiveness by comparing 4 groups of patients analyzing either clinical criterias and complementary diagnostic exams. Each group will be using one of the main available drugs in different frequencies. The main criteria will be the control of inflammation and of cistoid macular edema combined with the fewer colateral effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactJoão;Adriane Ribeiro;Feitosa
Universitary Center Christus (Centro Universitário Christus - Unichristus);Instituto Cearense de Oftalmologia (ICO)
Outcome results
None listed