Macular Edema following cataract surgery in Diabetic type 2 patients.
Suspended
- Conditions
- Diabetes Mellitus type 2Cataract
- Registration Number
- NL-OMON23857
- Lead Sponsor
- The Rotterdam Eye HospitalPO Box 700303000 LM Rotterdamtel: 010 4017777
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 170
Inclusion Criteria
1. Informed consent;
2. Cataract (LOCS-III grading to document severity);
Exclusion Criteria
1. Severity of cataract obstructing ophthalmic inspection (i.e. NO5, NC5, NO6, NC6, C5, P5) and/or (sufficiently accurate) OCT measurements (i.e. a Signal Strength Index < 35);
2. Any other corneal, media, retinal or optic nerve disorder, except stage I (AREDS) dry ARMD;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Incidence of DME. DME is defined as an increase in mean foveal thickness on OCT of 30% or more from preoperative baseline. No distinction will be made between Irvine-Gass syndrome or evolving diabetic maculopathy, as it is impossible to differentiate these entities and, moreover, this is clinically not relevant. As such, presence or absence of retinal microauneurysms, retinal exudates or cystoid pattern on OCT will not be taken into account to diagnose DME;<br><br /><br>2. Best Corrected Visual Acuity (ETDRS) at baseline, day 1, week 4, 12, 24 and 52;<br><br /><br>3. Mean Foveal Thickness (OCT) at baseline, day 1, week 4, 12, 24 and 52.<br>
- Secondary Outcome Measures
Name Time Method 1. Intraocular pressure at baseline, day 1, week 4, 12, 24 and 52;<br><br /><br>2. Laser Flare Measurement (Laser Flare Cell Meter) at baseline, day 1, week 4 and 12;<br><br /><br>3. Fundus photograph (ETDRS Grading) at baseline, week 24 and 52;<br><br /><br>4. VFQ-25 and diabetic Questionnaire at baseline, and week 52;<br><br /><br>5. Duration of DM will be registered, as well as a complete list of current medication and systemic comorbidity;<br><br /><br>6. Phacoemulsification parameters and duration of surgical intervention.<br>