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

Cairo University (CU) logo

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

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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