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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Corneal Endothelial Cell Loss; Mydriasis
• Intervention / Treatment: Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University - Kasr Alainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fydrane group; 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).; 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.; Other Names: Mydrane
No Intervention: Reference group: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: phacoemulsification; mydriasis; corneal endothelial cell count; Fydrane; mixed mydriatic and anaesthetic combination; intracameral mydriatic
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Postoperative Complications; Lens Diseases; Corneal Diseases; Pupil Disorders; Eye Manifestations; Cataract; Corneal Endothelial Cell Loss; Mydriasis
• Other Study ID Numbers: CU-oph-02-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No