EUCTR2012-004873-14-DE
Active, not recruiting
Phase 1
PREvention of Macular EDema after cataract surgery - PREMED
niversity Eye Clinic Maastricht0 sites1,135 target enrollmentMarch 6, 2015
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 phakoemulsification.
- •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
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 exclusion 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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Prevention of macular edema after cataract surgeryEUCTR2012-004873-14-BEniversity Eye Clinic Maastricht UMC1,008
Active, not recruiting
Phase 1
Prevention of macular edema after cataract surgeryCystoid Macular Edema (CME) after cataract surgeryTherapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2012-004873-14-NLniversity Eye Clinic Maastricht1,135
Active, not recruiting
Not Applicable
Prevention of macular edema after cataract surgeryPseudophakic cystoid macular edema (PCME)MedDRA version: 14.1Level: PTClassification code 10058202Term: Cystoid macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2012-004873-14-HUniversity Eye Clinic Maastricht1,350
Active, not recruiting
Phase 1
Prevention of macular edema after cataract surgeryPseudophakic cystoid macular edema (PCME)Therapeutic area: Diseases [C] - Eye Diseases [C11]EUCTR2012-004873-14-PTniversity Eye Clinic Maastricht1,008
Active, not recruiting
Phase 1
Prevention of macular edema after cataract surgeryEUCTR2012-004873-14-ESniversity Eye Clinic Maastricht1,350