Effect of drop-less surgery compared to topical NSAID alone and combination of steroid and NSAID on central macular thickness after cataract surgery, a randomized controlled trial - Study for optimizing anti-inflammatory prophylaxis, SOAP”

Dpt. of Ophthalmology, Rigshospitalet-Glostrup0 个研究点目标入组 470 人开始时间: 2017年6月30日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•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

•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
•Fertile women, i.e. women who are not menopausal.
•Women who breastfeed

发起方

Dpt. of Ophthalmology, Rigshospitalet-Glostrup