Macular changes after vitroretinal surgery
Conditions
Interventions
Trade Name: Aprednislon
Pharmaceutical Form: Tablet
Sponsors
Universitätsklinik für Augenheilkunde und Optometrie, MUW
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Vitreoretinal diseases involving the macula region, requiring vitreoretinal surgery (i.e. macular pucker, macular holes, vitreoretinal traction syndrome). - Age > 18 years - Visual acuity > 0.05 - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Relevant other ophthalmic diseases (such as glaucoma, cornea pathology, neuro-ophthalmic diseases, etc.) - Preceding vitreoretinal surgery or ocular trauma - Diabetes mellitus requiring medical control - Other diseases being contraindications towards systemic application of steroids (i.e. osteoporosis, right ventricular insufficiency, gastric/duodenal ulcers, coagulation disorders, psychiatric disorders, acute infections, Cushing syndrome, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: inraretinal morphology in the macula region;Secondary Objective: ETDRS visual acuity, Microperimetry imag;Primary end point(s): To assess the morphological and functional effect of systemic treatment with steroids on the postoperative outcome (i.e. increase in visual acuity or macular sensitivity, changes in macular thickness/volume and intraretinal layers) after vitreoretinal surgery in the macula region. | — |
Countries
Austria
Outcome results
None listed