Status:
COMPLETED
Study for Optimizing Anti-inflammatory Prophylaxis
Lead Sponsor:
Line Kessel
Conditions:
Postoperative Cystoid Macular Edema
Irvine-Gass Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate which anti-inflammatory treatment is best at preventing postoperative inflammation following cataract surgery. We want to compare topical prophylaxis with N...
Eligibility Criteria
Inclusion
- Patients with age-related cataracts
- Older than 18 years
- Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months.
- Capacity to consent
- Scheduled to undergo cataract surgery at the ophthalmic department at Rigshospitalet-Glostrup, Denmark
- The surgeon must be experienced, defined by a minimum of 1000 cataract extractions completed
- Only 1 eye can be included for each participant, but there are no restrictions as to whether it is the eye that undergoes surgery first or last. If both eyes of a participant are eligible, it will be decided by randomization which eye to be included in the study
- Informed consent to participation
Exclusion
- Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
- Medical history of epiretinal membrane, retinal vein occlusion, retinal detachment, uveitis, glaucoma, diabetes mellitus, exudative age-related macular degeneration (AMD) or AMD with geographical atrophy
- Significant complications to surgery such as posterior capsule rupture/vitreous loss, choroidal hemorrhage, and dislocated lens material
- Pregnancy
- Fertile women, i.e. women who are not menopausal.
- Women who breastfeed
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2019
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT03383328
Start Date
February 1 2018
End Date
December 18 2019
Last Update
December 20 2019
Active Locations (1)
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1
Department of Ophthalmology
Glostrup Municipality, Capital Region, Denmark, 2600