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.

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

Study Overview

• Status: Unknown
• Conditions: Cataract; Adverse Drug Event; Mydriasis
• Intervention / Treatment: Drug: Atropine sulfate and epinephrine; Drug: Topical cyclopentolate and phenylephrine

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ewais; Phone Number: +01223638543; Email: waelewais74@gmail.com
• Study Contact Backup: Name: Ali; Phone Number: +01005005707

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1261
      • Recruiting
      • Dar El Oyoun Hospital
      • Contact: Khaled Samir, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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.; Other Names: Atropine (Misr.co), Epinephrine (Misr.co)
Other: Topical cyclopentolate and phenylephrine; Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.	Drug: Topical cyclopentolate and phenylephrine; Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.; Other Names: Cyclophrine eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative pupil diameter	Intraoperative pupil diameter measurements of involved eye in mm	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dar El Oyoun Hospital
• Investigators: Principal Investigator: Nossair, Dar El Oyoun Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: cataract surgery; intraoperative mydriasis; subconjunctival atropine; intracameral epinephrine
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Eye Diseases; Lens Diseases; Pupil Disorders; Cataract; Drug-Related Side Effects and Adverse Reactions; Mydriasis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Epinephrine; Racepinephrine; Epinephryl borate; Atropine; Cyclopentolate; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: IRB 00001211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Identity and names of participant will be hidden. Data related to outcome measures can be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes