Glaucoma, Angle-ClosureNCT05328921
Effects of Systemic Drugs on Intraocular Pressure
An observational study of Glaucoma, Angle-Closure and Glaucoma Suspect, run by Benha University at 1 site in Egypt.
Trial summary
To assess intraocular pressure changes among glaucoma patients on systemic antihypertensive and antihistaminic drugs. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Glaucoma, Angle-Closure, Glaucoma Suspect, Glaucoma Secondary to Drugs, Bilateral
- What is being tested?
- Antihypertensive Agents and Antihistaminics
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Adult, Older adult
Study population: Glaucoma patients regularly visit glaucoma clinic at Banha university, EGYPT
Who may be able to join
- patients with narrow angle glaucoma on systemic antihypertensive and/or antihistaminic drugs.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy
Banhā, QA, 13511
Ahmed Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
Marwa Abdelshafy, MD, 01222328766 ext. Abdelshafy, ahmad4lg@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma, Angle-Closure, Glaucoma Suspect, Glaucoma Secondary to Drugs, Bilateral, Hypertension
- Being tested
- Antihypertensive Agents, Antihistaminics
- Keywords
- Angle closure glaucoma, Hypertension, Antihistaminic, Antihypertensive
- Medical subject headings
- Glaucoma, Angle-Closure, Ocular Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive AgentsDrug
Patients with narrow angle glaucoma and on systemic antihypertensive drugs.
AntihistaminicsDrug
Patients with narrow angle glaucoma and on systemic antihistaminic drugs.
| Study group | Role | What they receive |
|---|---|---|
| Antihypertensive drugs group | Changes in IOP among patients on antihypertensive drugs Receives: Drug: Antihypertensive Agents | |
| Antihistaminic drugs group | Changes in IOP among patients on antihistaminic drugs Receives: Drug: Antihistaminics | |
| Antihypertensive and antihistaminic drugs group | Changes in IOP among patients on both antihypertensive and antihistaminic drugs Receives: Drug: Antihypertensive Agents; Drug: Antihistaminics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intraocular pressure (IOP) measured by applanation tonometry
Changes in IOP measured by millimeter mercury (mmHg)
Measured: 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
Size of pupil measured in millimeters (mm) 7sing autorefractometer
Measured: Immediately after slit lamp examination and again on one and three months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start7 Apr 2022
- Primary completion15 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328921
- Sponsor's protocol ID
- Rc 9-22
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Systemic Drugs on Intraocular Pressure in Narrow Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05328921
- Acronym / sponsor ID
- Rc 9-22
- Conditions
- Glaucoma, Angle-Closure, Glaucoma Suspect, Glaucoma Secondary to Drugs, Bilateral, Hypertension
- Keywords
- Angle closure glaucoma, Hypertension, Antihistaminic, Antihypertensive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess intraocular pressure changes among glaucoma patients on systemic antihypertensive and antihistaminic drugs.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antihypertensive drugs group | – | Drug: Antihypertensive AgentsChanges in IOP among patients on antihypertensive drugs |
| Antihistaminic drugs group | – | Drug: AntihistaminicsChanges in IOP among patients on antihistaminic drugs |
| Antihypertensive and antihistaminic drugs group | – | Drug: Antihypertensive Agents, Drug: AntihistaminicsChanges in IOP among patients on both antihypertensive and antihistaminic drugs |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients regularly visit glaucoma clinic at Banha university, EGYPT
Key inclusion criteria (1 listed)
- patients with narrow angle glaucoma on systemic antihypertensive and/or antihistaminic drugs.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihypertensive AgentsPatients with narrow angle glaucoma and on systemic antihypertensive drugs. | Drug | Antihypertensive and antihistaminic drugs group, Antihypertensive drugs group |
| AntihistaminicsPatients with narrow angle glaucoma and on systemic antihistaminic drugs. | Drug | Antihistaminic drugs group, Antihypertensive and antihistaminic drugs group |
Primary outcome
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)
1 secondary outcome
Changes in pupil diameter
Time frame: Immediately after slit lamp examination and again on one and three months visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Angle-Closure and Glaucoma Suspect, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdelshafy, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.