Study for optimizing preventive treatment following cataract surgery - a randomized trial

Phase 1

• Conditions: Postoperative cystoid macular edema following cataract surgery; MedDRA version: 20.0Level: LLTClassification code 10070634Term: Irvine-Gass syndromeSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-002666-47-DK
• Lead Sponsor: Dpt. of Ophthalmology, Rigshospitalet-Glostrup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-30
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Criteria for 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
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 440

Exclusion Criteria

Criteria for 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified