A randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DMEC).

Oslo University Hospital0 个研究点目标入组 130 人开始时间: 2021年4月12日最近更新: 2021年6月21日

适应症

试验速览

暂无简介。

•Participants are eligible to be included in the study if all of the following criteria apply:
•Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
•Scheduled for DSAEK or DMEK
•Ability to cooperate fairly well during the examinations
•Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•Participants are excluded from the study if any of the following criteria apply:
•Contraindications for use of any medication (e.g. allergy, pregnancy, breastfeeding)
•oPregnancy or possible pregnancy during the study period is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5
•Preoperative macular edema and/or ongoing treatment for macular edema
•Re-transplantation
•In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
•Aphakic eyes
•Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
•For patients scheduled for corneal endothelial keratoplasty in both eyes, only the first operated eye will be included, however, both eyes will be examined.

发起方

Oslo University Hospital