Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco

Cataract Clinical Trial

Official title:

Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic Plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396301
• Other study ID #: CU-oph-02-2019
• Status: Completed
• Phase: Phase 3
• 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
• 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,

Related Conditions & MeSH terms

• Cataract
• Corneal Endothelial Cell Loss
• Mydriasis

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)