/A

Conditions: Macular changes after vitroretinal surgery

Registration Number: EUCTR2006-006871-19-AT

Lead Sponsor: niversitätsklinik für Augenheilkunde und Optometrie, MUW

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

- 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.)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>outcome (i.e. increase in visual acuity or macular sensitivity, changes in macular thickness/volume and<br>intraretinal layers) after vitreoretinal surgery in the macula region.

Secondary Outcome Measures