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Effects of Systemic Drugs on Intraocular Pressure

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05328921
Collaborator
(none)
200
Enrollment
1
Location
5.8
Anticipated Duration (Months)
34.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Effects of Two Systemic Drugs on Intraocular Pressure in Narrow Angle Glaucoma
Actual Study Start Date :
Apr 7, 2022
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Changes in intraocular pressure (IOP) measured by applanation tonometry [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)

Secondary Outcome Measures

  1. Changes in pupil diameter [Immediately after slit lamp examination and again on one and three months visit]

    Size of pupil measured in millimeters (mm) 7sing autorefractometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
ClinicalTrials.gov Identifier:
NCT05328921
Other Study ID Numbers:
  • Rc 9-22
First Posted:
Apr 14, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
Angle closure glaucoma
Hypertension
Antihistaminic
Antihypertensive
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Hypertension
Antihypertensive Agents

Study Results

No Results Posted as of Apr 14, 2022