Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Phase 4

• Conditions: Cataract; Mydriasis; Adverse Drug Event
• Interventions: Drug: Atropine sulfate and epinephrine; Drug: Topical cyclopentolate and phenylephrine

• Registration Number: NCT03638726
• Lead Sponsor: Dar El Oyoun Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Study Start: 2018-09-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-07
• Last Update Posted: 2018-10-09
• Primary Completion: 2019-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Cases of bilateral visually significant cataract

Exclusion Criteria

• Poor pupil dilation(less than 6 mm diameter).
• History of previous eye surgery or trauma
• History of use of eye drops affecting pupil size such as pilocarpine.
• Known drug allergy to cyclopentolate,phenylephrine, atropine sulfate or epinephrine.
• Pediatric age group (less than 18 years old).
• Pupil abnormalities, such as anisocoria or neurological disorders.
• Associated glaucoma, uveitis, corneal, retinal or optic nerve disease.
• Cases scheduled for phacoemulsification under general anaesthesia (to exclude possible ocular and systemic effects or interactions of anaesthetic agents).
• Patients with bleeding tendency or on anti-coagulant therapy (because peribulbar and subconjunctival injections are used).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine sulfate and Epinephrine	Atropine sulfate and epinephrine	Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist).
Topical cyclopentolate and phenylephrine	Topical cyclopentolate and phenylephrine	Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.

Primary Outcome Measures

Name	Time	Method
Intraoperative pupil diameter	1 day	Intraoperative pupil diameter measurements of involved eye in mm

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Starting from first postoperative day till one month.	Complications such as subconjunctival hemorrhage or corneal edema; \[Time Frame: starting from the first postoperative day till one month\]
Postoperative corneal thickness	1 month after surgery	Measured by specular microscopy in ( mm )
Postoperative corneal endothelial density	1 month after surgery	Measured by specular microscopy in ( cell number/mm2)
Postoperative pupil diameter	one day, one week and one month after surgery	Postoperative diameter of involved eye in mm
Postoperative visual acuity	One day, one week and one month after surgery	Postoperative best corrected distance visual acuity in logmar units.
Postoperative intraocular pressure (IOP)	One day, one week and one month after surgery	Postoperative IOP measured in mmHg

Trial Locations

Locations (1)

Dar El Oyoun Hospital; 🇪🇬 Cairo, Giza, Egypt