Treatment of Cystoid Macular Edema following cataract surgery. A randomized, double-masked, placebo-controlled, clinical trial.
Completed
- Conditions
- Cystoid Macular Edema (CME) after phacoemulsification.
- Registration Number
- NL-OMON26441
- Lead Sponsor
- Het Oogziekenhuis RotterdamPostbus 700303000 LM Rotterdam
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Diagnosed or suspect clinical CME within three months after phacoemulsification;
2. CME on OCT;
Exclusion Criteria
1. Diabetes mellitus I/II;
2. Corneal complications;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At 12 weeks:<br /><br>1. Optical Coherence Tomography (OCT)-proven CME (yes/no);<br /> <br>2. Best corrected visual acuity as determined by ETDRS. <br>
- Secondary Outcome Measures
Name Time Method 1. OCT-proven CME (yes/no);<br /> <br>2. Clinical CME (yes/no) (i.e CME with reduced visual acuity of 2 or more lines);<br /><br>3. Best corrected visual acuity as determined by ETDRS;<br /><br>4. Thickness of the macula, examined by OCT RTVue (Optovue);<br /><br>5. Active inflammation as measured by Laser flare count<br>