A Phase 3 interventional study of Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). in Corneal Endothelial Cell Loss, Mydriasis and Cataract, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Cairo University · Phase 3, Interventional, and Other
Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.
in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15 eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes (Reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.
28 studies on the registry are indexed under Corneal Endothelial Cell Loss; 6 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 16 interventional studies indexed under Corneal Endothelial Cell Loss.
Browse Corneal Endothelial Cell Loss studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Fydrane is injected intracamerally at the beginning of cataract surgery after the first incision, at a dose of 0.2 ml of solution, in only one injection. Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE). No preoperative topical eye drops are used.
Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
not injected with intracameral Fydrane. Pupillary dilatation in this group is achieved using preoperative topical eye drops: cyclopentolate hydrochloride 1% and tropicamide 1 % one drop every 15 min for 1 hour preoperatively.
Fydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml.
Also known as: Mydrane
safety of intracameral Fydrane on endothelial cell count
evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative
Time frame: 3 weeks postoperative
effect of Fydrane on pupil diameter during phacoemulsification
Fydrane Efficacy in achieving and maintaining mydiasis, is evaluated by measuring pupil diameter using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
Time frame: pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
Ran from Feb 2019 to primary completion in Aug 2019, 6 months.
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Corneal Endothelial Cell Loss →