NCT03638726

Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Dar El Oyoun Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.

Detailed description

The study will include 20 patients with bilateral cataract (40 eyes). The experimental group will include eyes for which a new injectable mydriatic combination are used to dilate the pupil. The control group will include cases where standard mydriatic eye drops are used.

Conditions

• Cataract
• Mydriasis
• Adverse Drug Event

Interventions

Type	Name	Description
DRUG	Atropine sulfate and epinephrine	Experimental arm:Combined use of subconjunctival atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral epinephrine 1:100000 ( sympathetic agonist). Control arm :topical mydriatics are used for pupil dilation.
DRUG	Topical cyclopentolate and phenylephrine	Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.

Timeline

• Start date: 2018-09-28
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2018-08-20
• Last updated: 2018-10-09

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study