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Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

Primary Purpose

Cataract, Mydriasis, Adverse Drug Event

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Atropine sulfate and epinephrine
Topical cyclopentolate and phenylephrine
Sponsored by
Dar El Oyoun Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract focused on measuring intraoperative mydriasis, subconjunctival atropine, intracameral epinephrine, cataract surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dar El Oyoun HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Atropine sulfate and Epinephrine

Topical cyclopentolate and phenylephrine

Arm Description

Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist).

Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.

Outcomes

Primary Outcome Measures

Intraoperative pupil diameter
Intraoperative pupil diameter measurements of involved eye in mm

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2018
Last Updated
October 7, 2018
Sponsor
Dar El Oyoun Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03638726
Brief Title
Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification
Official Title
Combined Subconjunctival Atropine and Intracameral Epinephrine Injection for Pupil Dilation in Phacoemulsification Under Peribulbar Anesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dar El Oyoun Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Mydriasis, Adverse Drug Event
Keywords
intraoperative mydriasis, subconjunctival atropine, intracameral epinephrine, cataract surgery

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical study
Masking
Outcomes Assessor
Masking Description
Preoperative and postoperative assessment will be done by a masked observer.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atropine sulfate and Epinephrine
Arm Type
Experimental
Arm Description
Perioperative pupil dilation is achieved by combined use of subconjunctival Atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral Epinephrine 1:100000 ( sympathetic agonist).
Arm Title
Topical cyclopentolate and phenylephrine
Arm Type
Other
Arm Description
Preoperative pupil dilation was achieved using topical cyclopentolate and phenylephrine.
Intervention Type
Drug
Intervention Name(s)
Atropine sulfate and epinephrine
Other Intervention Name(s)
Atropine (Misr.co), Epinephrine (Misr.co)
Intervention Description
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
Intervention Name(s)
Topical cyclopentolate and phenylephrine
Other Intervention Name(s)
Cyclophrine eye drops
Intervention Description
Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
Primary Outcome Measure Information:
Title
Intraoperative pupil diameter
Description
Intraoperative pupil diameter measurements of involved eye in mm
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Complications such as subconjunctival hemorrhage or corneal edema [Time Frame: starting from the first postoperative day till one month]
Time Frame
Starting from first postoperative day till one month.
Title
Postoperative corneal thickness
Description
Measured by specular microscopy in ( mm )
Time Frame
1 month after surgery
Title
Postoperative corneal endothelial density
Description
Measured by specular microscopy in ( cell number/mm2)
Time Frame
1 month after surgery
Title
Postoperative pupil diameter
Description
Postoperative diameter of involved eye in mm
Time Frame
one day, one week and one month after surgery
Title
Postoperative visual acuity
Description
Postoperative best corrected distance visual acuity in logmar units.
Time Frame
One day, one week and one month after surgery
Title
Postoperative intraocular pressure (IOP)
Description
Postoperative IOP measured in mmHg
Time Frame
One day, one week and one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ewais
Phone
+01223638543
Email
waelewais74@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali
Phone
+01005005707
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nossair
Organizational Affiliation
Dar El Oyoun Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dar El Oyoun Hospital
City
Cairo
State/Province
Giza
ZIP/Postal Code
1261
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled Samir, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Identity and names of participant will be hidden. Data related to outcome measures can be shared

Learn more about this trial

Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification

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