A Phase 3 interventional study of Control group and Dexamethasone group in Corneal Edema, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Cairo University · Phase 3, Interventional, and Prevention
Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
Intracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.
Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count.
Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
On the first postoperative day corneal edema in control compared to dexamethasone and TA groups respectively.
One month later, the mean increase of corneal thickness in control compared to intracameral dexamethasone and TA groups, respectively.
mean endothelial cell loss in control compared to intracameral dexamethasone and TA groups respectively.
45 studies on the registry are indexed under Corneal Edema; 7 are open to participants now.
This study's enrollment of 69 is above the median of 42 across 37 interventional studies indexed under Corneal Edema.
Browse Corneal Edema studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
23 eyes that did not receive any intraoperative steroids
Other: Control group
23 eyes that received intracameral dexamethasone
Drug: Dexamethasone group
23 eyes that received intracameral triamcinolone (TA)
Drug: Triamcinolone (TA) group
23 eyes that didn't receive any intraoperative steroids
Also known as: No intraoperative steroids
23 eyes each received intracameral dexamethasone at the conclusion of phacoemulsification Received intracameral 0.4 mg in / 0.1 ml dexamethasone (8mg/2ml®; Amriya or Epico) at the end of phacoemulsification.
Also known as: Intracameral Dexamethasone
23 eyes each received intracameral triamcinolone (TA) at the conclusion of phacoemulsification Received intracameral 2 mg/0.05 ml triamcinolone (TA) (Kenacort-A®; Bristol-Myers Squibb) at the end of phacoemulsification.
Also known as: Intracameral triamcinolone (TA)
Corneal edema
Clinical grade of corneal edema on the first postoperative day
Time frame: First day postoperative
Central corneal thickness (CCT)
Central corneal thickness in microns after phacoemulsification that was compared to preoperative values
Time frame: Three months
Endothelial cell loss
Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values
Time frame: Three months
IOP
Intraocular pressure in mmHg rise after after phacoemulsification
Time frame: Three months
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Cairo University