EUCTR2012-004873-14-NL
Active, not recruiting
Phase 1
PREvention of Macular EDema after cataract surgery - PREMED
niversity Eye Clinic Maastricht0 sites1,135 target enrollmentDecember 10, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cystoid Macular Edema (CME) after cataract surgery
- Sponsor
- niversity Eye Clinic Maastricht
- Enrollment
- 1135
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients undergoing routine phacoemulsification.
- •Only one eye per patient will be included in the study.
- •Patients should be able to communicate properly and understand instructions.
- •All patients must accept possible off\-label use of study medication before inclusion in this study.
- •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 208
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 927
Exclusion Criteria
- •Study procedures will be different for diabetic and non\-diabetic patients. Therefore, the exclusion criteria will also be different for diabetic and non\-diabetic patients.
- •General Eexclusion criteria for participation in this study are:
- •1\.age below 21 years old;
- •2\.participation in another clinical study;
- •3\.post\-traumatic cataract;
- •4\.combined surgery;
- •5\.functional monoculus;
- •6\.previous ocular surgery;
- •7\.progressive glaucoma with severe visual field defects, use of anti\-glaucomatous medication or steroid\-induced IOP elevation that required IOP\-lowering treatment;
- •8\.IOP \= 25 mmHg;
Outcomes
Primary Outcomes
Not specified
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