Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
NCT ID: NCT03638726
Last Updated: 2018-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2018-09-28
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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).
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.
Topical cyclopentolate and phenylephrine
Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.
Topical cyclopentolate and phenylephrine
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
Interventions
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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.
Topical cyclopentolate and phenylephrine
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Dar El Oyoun Hospital
OTHER
Responsible Party
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Dr. Ashraf Nossair, MD
Associate Professor of Ophthalmology, Cairo University
Principal Investigators
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Nossair
Role: PRINCIPAL_INVESTIGATOR
Dar El Oyoun Hospital
Locations
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Dar El Oyoun Hospital
Cairo, Giza Governorate, Egypt
Countries
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Central Contacts
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Ali
Role: CONTACT
Facility Contacts
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Khaled Samir, MD
Role: primary
Other Identifiers
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IRB 00001211
Identifier Type: -
Identifier Source: org_study_id
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