Cataract, Corneal Endothelial Cell Loss, Mydriasis
Conditions
Keywords
corneal endothelial cell count, Fydrane, mixed mydriatic and anaesthetic combination, intracameral mydriatic, mydriasis, phacoemulsification
Brief summary
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.
Detailed description
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.
Interventions
DRUGFydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* medium density cataract (nuclear II to III)
Exclusion criteria
* soft or hard density cataract (nuclear I or IV) * history of ocular trauma or previous intraocular surgery * iatrogenic, congenital or traumatic cataract * associated eye disease e.g. pseudoexofoliation syndrome * associated pre-existing corneal endothelial disease e.g. Fuchs dystrophy * associated systemic disease that can affect endothelium,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety of intracameral Fydrane on endothelial cell count | 3 weeks postoperative | evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect of Fydrane on pupil diameter during phacoemulsification | pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation) | 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) |
Countries
Egypt
Outcome results
None listed