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Trial record 4 of 10 for:    "Lens Disease" | "Phenylephrine"

Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

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ClinicalTrials.gov Identifier: NCT03638726
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Ashraf Nossair, MD, Dar El Oyoun Hospital

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

Condition or disease Intervention/treatment Phase
Cataract Mydriasis Adverse Drug Event Drug: Atropine sulfate and epinephrine Drug: Topical cyclopentolate and phenylephrine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical study
Masking: Single (Outcomes Assessor)
Masking Description: Preoperative and postoperative assessment will be done by a masked observer.
Primary Purpose: Other
Official Title: Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019


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 Name: Atropine (Misr.co), Epinephrine (Misr.co)

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 Name: Cyclophrine eye drops




Primary Outcome Measures :
  1. Intraoperative pupil diameter [ Time Frame: 1 day ]
    Intraoperative pupil diameter measurements of involved eye in mm


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: Starting from first postoperative day till one month. ]

    Complications such as subconjunctival hemorrhage or corneal edema

    [Time Frame: starting from the first postoperative day till one month]


  2. Postoperative corneal thickness [ Time Frame: 1 month after surgery ]
    Measured by specular microscopy in ( mm )

  3. Postoperative corneal endothelial density [ Time Frame: 1 month after surgery ]
    Measured by specular microscopy in ( cell number/mm2)

  4. Postoperative pupil diameter [ Time Frame: one day, one week and one month after surgery ]
    Postoperative diameter of involved eye in mm

  5. Postoperative visual acuity [ Time Frame: One day, one week and one month after surgery ]
    Postoperative best corrected distance visual acuity in logmar units.

  6. Postoperative intraocular pressure (IOP) [ Time Frame: One day, one week and one month after surgery ]
    Postoperative IOP measured in mmHg



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638726


Contacts
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Contact: Ewais +01223638543 waelewais74@gmail.com
Contact: Ali +01005005707

Locations
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Egypt
Dar El Oyoun Hospital Recruiting
Cairo, Giza, Egypt, 1261
Contact: Khaled Samir, MD         
Sponsors and Collaborators
Dar El Oyoun Hospital
Investigators
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Principal Investigator: Nossair Dar El Oyoun Hospital

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Responsible Party: Dr. Ashraf Nossair, MD, Associate Professor of Ophthalmology, Cairo University, Dar El Oyoun Hospital
ClinicalTrials.gov Identifier: NCT03638726     History of Changes
Other Study ID Numbers: IRB 00001211
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Identity and names of participant will be hidden. Data related to outcome measures can be shared

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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
Keywords provided by Dr. Ashraf Nossair, MD, Dar El Oyoun Hospital:
intraoperative mydriasis
subconjunctival atropine
intracameral epinephrine
cataract surgery
Additional relevant MeSH terms:
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Lens Diseases
Phenylephrine
Oxymetazoline
Cataract
Mydriasis
Drug-Related Side Effects and Adverse Reactions
Eye Diseases
Chemically-Induced Disorders
Pupil Disorders
Atropine
Epinephrine
Racepinephrine
Ophthalmic Solutions
Cyclopentolate
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents