Trial | NCT03638726  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
Mydriatic eye drops are routinely used before phacoemulsification but they are not free of drawbacks. Several alternatives were tried to overcome their limitations.
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 Started
Sep 28
2018
Primary Completion
Mar 31
2019
Anticipated
Study Completion
Jun 30
2019
Anticipated
Last Update
Oct 09
2018

Drug Atropine sulfate and epinephrine [atropine, epinephrine (levophed)]

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.

  • Other names: Atropine (Misr.co), Epinephrine (Misr.co)

Drug Topical cyclopentolate and phenylephrine [cyclopentolate (cyclogyl), phenylephrine (Prefrin)]

Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.

  • Other names: Cyclophrine eye drops

Atropine sulfate and Epinephrine Experimental

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 Other

Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.

Criteria 

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).
No Results Posted