Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

NCT ID: NCT03638726

Last Updated: 2018-10-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2019-06-30

Brief Summary

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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

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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

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Cataract Mydriasis Adverse Drug Event

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical study
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Preoperative and postoperative assessment will be done by a masked observer.

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).

Group Type EXPERIMENTAL

Atropine sulfate and epinephrine

Intervention Type DRUG

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.

Group Type OTHER

Topical cyclopentolate and phenylephrine

Intervention Type DRUG

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.

Intervention Type DRUG

Topical cyclopentolate and phenylephrine

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

Intervention Type DRUG

Other Intervention Names

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Atropine (Misr.co), Epinephrine (Misr.co) Cyclophrine eye drops

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dar El Oyoun Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ashraf Nossair, MD

Associate Professor of Ophthalmology, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ewais

Role: CONTACT

+01223638543

Ali

Role: CONTACT

+01005005707

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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