Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT01657500
Group ID:
EG001
Title:
Optisol GS
Description:
Donor cornea is stored in the Optisol GS media prior to transplantation
Corneal donor storage in Optisol GS media solution: Donor tissue is preserved in the Optisol media until ready for transplantation In the early postoperative period, 1 DSAEK graft in the Optisol GS group was repositioned because it fully detached. Air was reinjected in 2 eyes to treat partial graft detachment. During the 6-month follow-up period, 1 graft experienced a graft rejection episodes, which responded to increased topical corticosteroid therapy. 7 eyes had intraocular pressure (IOP) elevation requiring use of glaucoma medications or reduction of topical corticosteroid strength or dosing frequency. 2 eyes had laser capsulotomy to treat capsular haze. 1 eye had a vitreous strand associated with a capsular tear during cataract removal and was treated with laser vitreolysis.Altogether, 14 of 27 eyes (52%) in each corneal storage solution group had a postoperative intervention (P = 1.0).
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
27
Other Number Affected:
0
Other Number At Risk:
27
Study:
NCT01657500
Results Section:
NCT01657500
Adverse Events Module:
NCT01657500