Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Dar El Oyoun Hospital

Status and phase: Unknown; Phase 4

Conditions: Adverse Drug Event; Cataract; Mydriasis

Treatments: Drug: Atropine sulfate and epinephrine; Drug: Topical cyclopentolate and phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03638726

IRB 00001211

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Atropine sulfate and Epinephrine

Experimental group

Description:

Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist).

Treatment:

Drug: Atropine sulfate and epinephrine

Topical cyclopentolate and phenylephrine

Other group

Description:

Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.

Treatment:

Drug: Topical cyclopentolate and phenylephrine