NCT05328921

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

April 7, 2022

Last Update Submit

April 7, 2022

Conditions

Glaucoma, Angle-ClosureGlaucoma SuspectGlaucoma Secondary to Drugs, BilateralHypertension

Keywords

Angle closure glaucomaHypertensionAntihistaminicAntihypertensive

Outcome Measures

Primary Outcomes (1)

  • Changes in intraocular pressure (IOP) measured by applanation tonometry

    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 Outcomes (1)

  • Changes in pupil diameter

    Immediately after slit lamp examination and again on one and three months visit

Study Arms (3)

Antihypertensive drugs group

Changes in IOP among patients on antihypertensive drugs

Drug: Antihypertensive Agents

Antihistaminic drugs group

Changes in IOP among patients on antihistaminic drugs

Drug: Antihistaminics

Antihypertensive and antihistaminic drugs group

Changes in IOP among patients on both antihypertensive and antihistaminic drugs

Drug: Antihypertensive AgentsDrug: Antihistaminics

Interventions

Antihypertensive AgentsDRUG

Patients with narrow angle glaucoma and on systemic antihypertensive drugs.

Antihypertensive and antihistaminic drugs groupAntihypertensive drugs group
AntihistaminicsDRUG

Patients with narrow angle glaucoma and on systemic antihistaminic drugs.

Antihistaminic drugs groupAntihypertensive and antihistaminic drugs group

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Glaucoma patients regularly visit glaucoma clinic at Banha university, EGYPT

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-ClosureOcular HypertensionHypertension

Interventions

Antihypertensive AgentsHistamine Antagonists

Condition Hierarchy (Ancestors)

GlaucomaEye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesHistamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPhysiological Effects of Drugs

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

01222328766ahmad4lg@gmail.com

Marwa Abdelshafy, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

April 7, 2022

Primary Completion

September 15, 2022

Study Completion

September 30, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

EG(1)