Macular EdemaNCT05209971
Macular Thickness and Visual Acuity in Diabetic Hypertensive Patients
An observational study of Macular Edema, run by Sohag University.
Trial summary
In this study, measurements of central macular thickness using optical coherence tomography along with examination of visual acuity by Snellen's chart in diabetic hypertensive patients will be done . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective study of patients of type 2 diabetes with hypertension
Who may be able to join
- Type 2 diabetic patients with hypertension .
Who cannot join
- Patients with type 1 diabetes mellitus .
- Ocular disease ( such as high myopia , glaucoma ) .
- Patients with opacities in the media ( corneal opacities , dense cataract , vitreous hemorrhage ) .
- Systemic medication (Tamoxifen , Chloroquine , Canthaxanthine ) to avoid its effect on macular thickness .
- Central visual field defect that prevents fixation on OCT .
- Intraocular inflammation such as anterior or posterior uveitis .
- Refractive error greater than 6 diopter .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Macular Thickness and Visual Acuity in Diabetic Hypertensive Patients in Sohag City
In this study, measurements of central macular thickness using optical coherence tomography along with examination of visual acuity by Snellen's chart in diabetic hypertensive patients will be done .
Read the detailed description
correlate relationship between optical coherence tomography changes and visual acuity in patients with type 2 diabetes and hypertension
- Conditions
- Macular Edema
- Keywords
- Macular thickness and visual acuity
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| macular thickness and visual acuity | optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular thickness in diabetic hypertensive patients
measurement of central macular thickness by optical coherence tomography
Measured: June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study startJan 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda Abdelraheem Abdellah, Sohag University
- Investigators
- Raghda Abdelraheem, doctor, Principal investigator, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209971
- Sponsor's protocol ID
- Soh-Med-22-01-05
- Status last verified
- Jan 2022
- First submitted
- 13 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: measurement of macular thickness
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Thickness and Visual Acuity in Diabetic Hypertensive Patients in Sohag City
- ClinicalTrials.gov ID
- NCT05209971
- Acronym / sponsor ID
- Soh-Med-22-01-05
- Conditions
- Macular Edema
- Keywords
- Macular thickness and visual acuity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Jan 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.
In this study, measurements of central macular thickness using optical coherence tomography along with examination of visual acuity by Snellen's chart in diabetic hypertensive patients will be done .
Detailed description
correlate relationship between optical coherence tomography changes and visual acuity in patients with type 2 diabetes and hypertension
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| macular thickness and visual acuity | – | –optical coherence tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective study of patients of type 2 diabetes with hypertension
Key inclusion criteria (1 listed)
- Type 2 diabetic patients with hypertension .
Key exclusion criteria (7 listed)
- Patients with type 1 diabetes mellitus .
- Ocular disease ( such as high myopia , glaucoma ) .
- Patients with opacities in the media ( corneal opacities , dense cataract , vitreous hemorrhage ) .
- Systemic medication (Tamoxifen , Chloroquine , Canthaxanthine ) to avoid its effect on macular thickness .
- Central visual field defect that prevents fixation on OCT .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
macular thickness in diabetic hypertensive patients
Time frame: June 2022
measurement of central macular thickness by optical coherence tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No. measurement of macular thickness
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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.
Raghda Abdelraheem, doctor principal investigator
faculty of medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema, run by Sohag University.
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 7 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Gamal Abdelateef, professor (01001244421, raghdaabdelraheem89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
macular thickness in diabetic hypertensive patients (time frame: June 2022). 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 27 Jan 2022.