Ocular Changes With Alpha-2 Receptor Agonist.

January 2, 2023 updated by: Ahmed Abdelshafy, Benha University

Ocular Changes After Selective Alpha-2 Receptor Agonist.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • QA
      • Banhā, QA, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: Baseline and 6 months after regular use of the topical eyedrops
Changes in intraocular pressure measured in mmHg by applanation tonometry
Baseline and 6 months after regular use of the topical eyedrops

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pupillary diameter
Time Frame: Baseline and 6 months after regular use of the topical eyedrops
Changes in the pupillary diameter measured in mm by handheld pupillometer
Baseline and 6 months after regular use of the topical eyedrops

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

August 10, 2023

Study Completion (Anticipated)

September 22, 2023

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 2, 2023

First Posted (Estimate)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-2-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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