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

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Cataract; Corneal Endothelial Cell Loss; Mydriasis

Treatments: Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).

Study type: Interventional

Funder types: Other

Identifiers

NCT04396301

CU-oph-02-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Fydrane group

Active Comparator group

Description:

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.

Treatment:

Drug: Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).

Reference group:

No Intervention group

Description:

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.