Glaucoma, SuspectNCT05670015
Ocular Changes With Alpha-2 Receptor Agonist.
A study testing Low dosage selective alpha-2 receptor agonists topical eyedrop and High dosage selective alpha-2 receptor agonists topical eyedrop in people with Glaucoma, Suspect and Aberration, Corneal Wavefront, run by Benha University at 1 site in Egypt.
Trial summary
selective alpha-2 receptor agonists cause changes in intraocular pressure and pupillary size thus may affect patient quality of life. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Glaucoma, Suspect, Aberration, Corneal Wavefront
- What is being tested?
- Low dosage selective alpha-2 receptor agonists topical eyedrop and High dosage selective alpha-2 receptor agonists topical eyedrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 22 Sep 2023
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Glaucoma suspect cases.
- post-refractive surgery cases.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy
Banhā, QA, 13511
Ahmed Abdelshafy, 01222328766, ahmad4lg@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma, Suspect, Aberration, Corneal Wavefront
- Being tested
- Low dosage selective alpha-2 receptor agonists topical eyedrop, High dosage selective alpha-2 receptor agonists topical eyedrop
- Keywords
- Glaucoma suspect, Post-lasik
- Medical subject headings
- Ocular Hypertension, Corneal Wavefront Aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dosage selective alpha-2 receptor agonists topical eyedropDrug
Also called Topical selective alpha-2 receptor agonists
Using selective alpha-2 receptor agonists eyedrop in both groups with 0.2% concentration.
High dosage selective alpha-2 receptor agonists topical eyedropDrug
Also called Topical selective alpha-2 receptor agonists
Using selective alpha-2 receptor agonists eyedrop in both groups with 0.02% concentration.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma suspect group | Active comparator | Cases diagnosed as glaucoma suspect Receives: Drug: Low dosage selective alpha-2 receptor agonists topical eyedrop; Drug: High dosage selective alpha-2 receptor agonists topical eyedrop |
| Post-refractive surgery group | Active comparator | Cases had undergone refractive surgery Receives: Drug: Low dosage selective alpha-2 receptor agonists topical eyedrop; Drug: High dosage selective alpha-2 receptor agonists topical eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Changes in intraocular pressure measured in mmHg by applanation tonometry
Measured: Baseline and 6 months after regular use of the topical eyedrops
Secondary outcomes (1)
Pupillary diameter
Changes in the pupillary diameter measured in mm by handheld pupillometer
Measured: Baseline and 6 months after regular use of the topical eyedrops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jan 2023
- Primary completion10 Aug 2023 (estimated)
- Study completion22 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, SuspectStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Abdelshafy, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670015
- Sponsor's protocol ID
- RC-2-2023
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Changes After Selective Alpha-2 Receptor Agonist.
- ClinicalTrials.gov ID
- NCT05670015
- Acronym / sponsor ID
- RC-2-2023
- Conditions
- Glaucoma, Suspect, Aberration, Corneal Wavefront
- Keywords
- Glaucoma suspect, Post-lasik
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Aug 2023 (estimated)
- Study completion
- 22 Sep 2023 (estimated)
- First posted
- 4 Jan 2023 (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.
selective alpha-2 receptor agonists cause changes in intraocular pressure and pupillary size thus may affect patient quality of life.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma suspect group | Active comparator | Drug: Low dosage selective alpha-2 receptor agonists topical eyedrop, Drug: High dosage selective alpha-2 receptor agonists topical eyedropCases diagnosed as glaucoma suspect |
| Post-refractive surgery group | Active comparator | Drug: Low dosage selective alpha-2 receptor agonists topical eyedrop, Drug: High dosage selective alpha-2 receptor agonists topical eyedropCases had undergone refractive surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Glaucoma suspect cases.
- post-refractive surgery cases.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Low dosage selective alpha-2 receptor agonists topical eyedropAlso: Topical selective alpha-2 receptor agonistsUsing selective alpha-2 receptor agonists eyedrop in both groups with 0.2% concentration. | Drug | Glaucoma suspect group, Post-refractive surgery group |
| High dosage selective alpha-2 receptor agonists topical eyedropAlso: Topical selective alpha-2 receptor agonistsUsing selective alpha-2 receptor agonists eyedrop in both groups with 0.02% concentration. | Drug | Glaucoma suspect group, Post-refractive surgery group |
Primary outcome
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
1 secondary outcome
Pupillary diameter
Time frame: Baseline and 6 months after regular use of the topical eyedrops
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Ahmed A Abdelshafy, MD principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dosage selective alpha-2 receptor agonists topical eyedrop and High dosage selective alpha-2 receptor agonists topical eyedrop in people with Glaucoma, Suspect and Aberration, Corneal Wavefront, 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 2 inclusion and 2 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 4 Jan 2023. 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?
Intraocular pressure (time frame: Baseline and 6 months after regular use of the topical eyedrops). 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 4 Jan 2023.