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Macular Edema following cataract surgery in Diabetic type 2 patients

Completed
Conditions
diabetic macular edema
10047060
10018424
Registration Number
NL-OMON33232
Lead Sponsor
Oogziekenhuis Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
170
Inclusion Criteria

- Informed consent
- Cataract
- Diabetes Mellitus type 2
- Mild to moderate non-proliferative diabetic retinopathy

Exclusion Criteria

- 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).
- Any other corneal, media, retinal or optic nerve disorder, except stage I dry ARMD
- Clinically significant macular edema
- Pregnant, no active birth control
- Use of Diamox
- Use of Avandia (rosiglitazone)
- Use of oral steroids
- Use of Coumarin derivatives and heparin derivatives
- Status after ablatio retina/vitrectomy
- History of steroid response

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Incidence DME, BCVA, foveal thickness. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>IOP.</p><br>
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