Effects of Systemic Drugs on Intraocular Pressure

April 7, 2022 updated by: Ahmed Abdelshafy, Benha University

Effects of Two Systemic Drugs on Intraocular Pressure in Narrow Angle Glaucoma

To assess intraocular pressure changes among glaucoma patients on systemic antihypertensive and antihistaminic drugs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Changes in intraocular pressure in glaucomatous patients with narrow angle may elicit attacks of angle closure glaucoma.

In this study we aim to assess changes in intraocular pressure (IOP) among glaucomatous patients on systemic antihypertensive and antihistaminic drugs.

Study Type

Observational

Enrollment (Anticipated)

200

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:
        • Principal Investigator:
          • Ahmed Abdelshafy, MD
        • 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

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Glaucoma patients regularly visit glaucoma clinic at Banha university, EGYPT

Description

Inclusion Criteria:

  • patients with narrow angle glaucoma on systemic antihypertensive and/or antihistaminic drugs.

Exclusion Criteria:

  • open angle glaucoma patients confirmed by gonioscopy examination.
  • Cases with dense corneal opacity or iris trauma that may affects gonioscopy examination.
  • cases with secondary glaucoma.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Antihypertensive drugs group
Changes in IOP among patients on antihypertensive drugs
Drug: Antihypertensive Agents
Patients with narrow angle glaucoma and on systemic antihypertensive drugs.
Antihistaminic drugs group
Changes in IOP among patients on antihistaminic drugs
Drug: Antihistaminics
Patients with narrow angle glaucoma and on systemic antihistaminic drugs.
Antihypertensive and antihistaminic drugs group
Changes in IOP among patients on both antihypertensive and antihistaminic drugs
Drug: Antihypertensive Agents
Patients with narrow angle glaucoma and on systemic antihypertensive drugs.
Drug: Antihistaminics
Patients with narrow angle glaucoma and on systemic antihistaminic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in intraocular pressure (IOP) measured by applanation tonometry
Time Frame: Immediately after visual acuity assessment for each eye after topical anesthetic eye drops and again on one and three months visit
Changes in IOP measured by millimeter mercury (mmHg)
Immediately after visual acuity assessment for each eye after topical anesthetic eye drops and again on one and three months visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pupil diameter
Time Frame: Immediately after slit lamp examination and again on one and three months visit
Size of pupil measured in millimeters (mm) 7sing autorefractometer
Immediately after slit lamp examination and again on one and three months visit

Collaborators and Investigators

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

Sponsor

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)

April 7, 2022

Primary Completion (Anticipated)

September 15, 2022

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc 9-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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