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

Phase 3

Completed

• Conditions: Cataract; Corneal Endothelial Cell Loss; Mydriasis

• Registration Number: NCT04396301
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-08-30
• Study Completion: 2019-09-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-20
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Cairo University - Kasr Alainy hospital; 🇪🇬 Cairo, Egypt