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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04396301
Other study ID # CU-oph-02-2019
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 1, 2019
Est. completion date September 30, 2019

Study information

Verified date May 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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,

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fydrane®: (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.

Locations

Country Name City State
Egypt Cairo University - Kasr Alainy hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 weeks postoperative
Secondary 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) pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)
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