Skip to main content
OpenTrials
Completed

NCT Number: NCT04396301

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Corneal Endothelial Cell Loss Cataract Corneal Diseases Eye Diseases Eye Manifestations Lens Diseases Mydriasis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pupil Disorders Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University - Kasr Alainy hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).

Drug

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

Primary outcomes

  1. safety of intracameral Fydrane on endothelial cell count

    Time frame: 3 weeks postoperative

    evaluates safety of Fydrane on corneal endothelium, assessed by calculating percentage of endothelial cell loss at 3 weeks postoperative

Secondary outcomes

  1. effect of Fydrane on pupil diameter during phacoemulsification

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 20, 2020
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.