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

Cairo University30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Corneal Endothelial Cell Loss Mydriasis Cataract

Interventions

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 Years

Medical Language ↔ Plain English

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,

Locations (1)

Cairo University - Kasr Alainy hospital

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 3 weeks postoperative

Secondary Outcomes

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)

Time frame: pupil diameter is measured using surgical caliper at certain timings during surgery (before capsulorhexis and before IOL implantation)

Data from ClinicalTrials.gov

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