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Ocular Changes With Alpha-2 Receptor Agonist.

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05670015
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
8.7
Anticipated Duration (Months)
17.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

selective alpha-2 receptor agonists cause changes in intraocular pressure and pupillary size thus may affect patient quality of life.

Condition or Disease Intervention/Treatment Phase
  • Drug: Low dosage selective alpha-2 receptor agonists topical eyedrop
  • Drug: High dosage selective alpha-2 receptor agonists topical eyedrop
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Ocular Changes After Selective Alpha-2 Receptor Agonist.
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Aug 10, 2023
Anticipated Study Completion Date :
Sep 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Glaucoma suspect group

Cases diagnosed as glaucoma suspect

Drug: Low dosage selective alpha-2 receptor agonists topical eyedrop
Using selective alpha-2 receptor agonists eyedrop in both groups with 0.2% concentration.
Other Names:
  • Topical selective alpha-2 receptor agonists

    • Drug: High dosage selective alpha-2 receptor agonists topical eyedrop
    Using selective alpha-2 receptor agonists eyedrop in both groups with 0.02% concentration.
    Other Names:
  • Topical selective alpha-2 receptor agonists

    		•
    Active Comparator: Post-refractive surgery group

    Cases had undergone refractive surgery

    Drug: Low dosage selective alpha-2 receptor agonists topical eyedrop
    Using selective alpha-2 receptor agonists eyedrop in both groups with 0.2% concentration.
    Other Names:
  • Topical selective alpha-2 receptor agonists

    • Drug: High dosage selective alpha-2 receptor agonists topical eyedrop
    Using selective alpha-2 receptor agonists eyedrop in both groups with 0.02% concentration.
    Other Names:
  • Topical selective alpha-2 receptor agonists

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure [Baseline and 6 months after regular use of the topical eyedrops]

      Changes in intraocular pressure measured in mmHg by applanation tonometry

    Secondary Outcome Measures

    1. Pupillary diameter [Baseline and 6 months after regular use of the topical eyedrops]

      Changes in the pupillary diameter measured in mm by handheld pupillometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Abdelshafy Banhā QA Egypt 13511

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Principal Investigator: Ahmed A Abdelshafy, MD, Benha University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abdelshafy, Assistant professor of Ophthalmology, Benha University
    ClinicalTrials.gov Identifier:
    NCT05670015
    Other Study ID Numbers:
    • RC-2-2023
    First Posted:
    Jan 4, 2023
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Abdelshafy, Assistant professor of Ophthalmology, Benha University
    Glaucoma suspect
    Post-lasik
    Additional relevant MeSH terms:
    Glaucoma
    Ocular Hypertension
    Corneal Wavefront Aberration
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Jan 4, 2023