Back to resultsOcular Changes With Alpha-2 Receptor Agonist.
Primary Purpose
Glaucoma, Suspect, Aberration, Corneal Wavefront
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Low dosage selective alpha-2 receptor agonists topical eyedrop
High dosage selective alpha-2 receptor agonists topical eyedrop
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma, Suspect focused on measuring Glaucoma suspect, Post-lasik
Eligibility Criteria
Inclusion Criteria: Glaucoma suspect cases. post-refractive surgery cases. Exclusion Criteria: Cases with prostatic hyperplasia or diabetics that may alter the measurements of pupillary diameter. Cases with previous history of any retinal intervention or other drugs that may alter intraocular pressure measurements.
Sites / Locations
- Ahmed AbdelshafyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Glaucoma suspect group
Post-refractive surgery group
Arm Description
Cases diagnosed as glaucoma suspect
Cases had undergone refractive surgery
Outcomes
Primary Outcome Measures
Intraocular pressure
Changes in intraocular pressure measured in mmHg by applanation tonometry
Secondary Outcome Measures
Pupillary diameter
Changes in the pupillary diameter measured in mm by handheld pupillometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05670015
Brief Title
Ocular Changes With Alpha-2 Receptor Agonist.
Official Title
Ocular Changes After Selective Alpha-2 Receptor Agonist.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 10, 2023 (Anticipated)
Study Completion Date
September 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
selective alpha-2 receptor agonists cause changes in intraocular pressure and pupillary size thus may affect patient quality of life.
Detailed Description
In this research, we will analyze the effect of selective alpha-2 receptor agonists on the human eye and investigate ocular changes over 6 months after its topical use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Suspect, Aberration, Corneal Wavefront
Keywords
Glaucoma suspect, Post-lasik
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma suspect group
Arm Type
Active Comparator
Arm Description
Cases diagnosed as glaucoma suspect
Arm Title
Post-refractive surgery group
Arm Type
Active Comparator
Arm Description
Cases had undergone refractive surgery
Intervention Type
Drug
Intervention Name(s)
Low dosage selective alpha-2 receptor agonists topical eyedrop
Other Intervention Name(s)
Topical selective alpha-2 receptor agonists
Intervention Description
Using selective alpha-2 receptor agonists eyedrop in both groups with 0.2% concentration.
Intervention Type
Drug
Intervention Name(s)
High dosage selective alpha-2 receptor agonists topical eyedrop
Other Intervention Name(s)
Topical selective alpha-2 receptor agonists
Intervention Description
Using selective alpha-2 receptor agonists eyedrop in both groups with 0.02% concentration.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
Changes in intraocular pressure measured in mmHg by applanation tonometry
Time Frame
Baseline and 6 months after regular use of the topical eyedrops
Secondary Outcome Measure Information:
Title
Pupillary diameter
Description
Changes in the pupillary diameter measured in mm by handheld pupillometer
Time Frame
Baseline and 6 months after regular use of the topical eyedrops
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Glaucoma suspect cases.
post-refractive surgery cases.
Exclusion Criteria:
Cases with prostatic hyperplasia or diabetics that may alter the measurements of pupillary diameter.
Cases with previous history of any retinal intervention or other drugs that may alter intraocular pressure measurements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Abdelshafy, MD
Phone
01008128810
Email
drmarwatabl2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdelshafy
City
Banhā
State/Province
QA
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy
Phone
01222328766
Email
ahmad4lg@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Ocular Changes With Alpha-2 Receptor Agonist.
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