Demographic ProfilesNCT06900855
Patients Seeking a Visual Impairment Certificate
An observational study of Demographic Profiles and Impairment Certificates, run by Assiut University.
Trial summary
This study investigates the prevalence, causes, and demographic characteristics of patients seeking visual impairment certificates at Assiut Ophthalmology Hospital. Using a prospective cross-sectional design, it aims to identify the magnitude and nature of visual impairment in this population by analyzing clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Demographic Profiles, Impairment Certificates, Visual Impairment
- How many people
- 383 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants undergo comprehensive eye examinations, including visual acuity measurement using Snellen charts, slit-lamp biomicroscopy, dilated fundus examination, and automated perimetry for visual field assessment. Advanced investigations such as OCT macula imaging, VEP (visual evoked potential), ERG (electroretinography), ultrasound, and fundus photography are performed to identify the causes of visual impairment. Demographic data-such as age, sex, marital status, occupation, socioeconomic status, education level-and systemic medical history are collected to assess contributing factors.
Who may be able to join
- Patients requesting visual impairment certificate at Assiut ophthalmology hospital having all investigations Visual field, OCT macula, VEP, ERG, US, Fundus photography Werepatients who fulfilled WHO's definition of blindness. The blind patients according to WHO's,were defined as patients having best corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10 or less in the widest diameter of vision.
Who cannot join
- Patients unwilling to participate in the study Incomplete or missing investigations
About this study
Official title: Prevalence, Causes and Demographic Profile of Patients Seeking a Visual Impairment Certificate
This study investigates the prevalence, causes, and demographic characteristics of patients seeking visual impairment certificates at Assiut Ophthalmology Hospital. Using a prospective cross-sectional design, it aims to identify the magnitude and nature of visual impairment in this population by analyzing clinical data, performing comprehensive eye examinations, and utilizing advanced diagnostic tools.
Read the detailed description
The study is designed to explore the prevalence, underlying causes, and demographic profiles of patients requesting visual impairment certificates at Assiut Ophthalmology Hospital. It employs a prospective cross-sectional approach, recruiting patients from ophthalmology outpatient clinics who meet the World Health Organization's (WHO) definition of blindness. Blindness is defined as having best-corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10° or less in the widest diameter of vision.
Eligible participants undergo comprehensive eye examinations, including visual acuity measurement using Snellen charts, slit-lamp biomicroscopy, dilated fundus examination, and automated perimetry for visual field assessment. Advanced investigations such as OCT macula imaging, VEP (visual evoked potential), ERG (electroretinography), ultrasound, and fundus photography are performed to identify the causes of visual impairment. Demographic data-such as age, sex, marital status, occupation, socioeconomic status, education level-and systemic medical history are collected to assess contributing factors.
The sample size was calculated using Epi-info software with a confidence level of 95% and confidence limits of 5%, estimating a minimum of 383 cases. By analyzing clinical findings alongside demographic characteristics, the study aims to provide valuable insights into the magnitude and nature of visual impairment in this specific population. This information could help inform public health strategies and improve services for visually impaired individuals.
- Keywords
- visual impairment, demographic profiles, visual impairment certificates
- Medical subject headings
- Vision Disorders
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 |
|---|---|---|
| Patients Seeking Visual Impairment Certificates at Assiut Ophthalmology Hospital | The study population consists of patients requesting visual impairment certificates at Assiut Ophthalmology Hospital, who have undergone all required investigations, including visual field testing, OCT macula imaging, VEP, ERG, ultrasound, and fundus photography. Eligible participants are those fulfilling WHO's definition of blindness, defined as having best-corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10° or less in the widest diameter of vision. Excluded are patients unwilling to participate or with incomplete/missing investigations. A calculated sample size of 383 cases ensures statistical reliability. Demographic and clinical data such as age, sex, occupation, socioeconomic status, marital status, education level, and associated systemic conditions are collected alongside comprehensive eye examinations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
BCVA of 3/60 or less in the better eye visual field restricted to 10 or less in the widest diameter of vision.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Demographic ProfilesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 383 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madona Gerges Boles, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900855
- Sponsor's protocol ID
- visual impairment certificate
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
International Journal of Research in Medical Sciences Priya M et al. Int J Res Med Sci. 2023 Aug
Bourne et al. (2013). Prevalence and causes of vision loss in high-income countries: a review. Lancet Global Health
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Causes and Demographic Profile of Patients Seeking a Visual Impairment Certificate
- ClinicalTrials.gov ID
- NCT06900855
- Acronym / sponsor ID
- visual impairment certificate
- Keywords
- visual impairment, demographic profiles, visual impairment certificates
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 383 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 28 Mar 2025 (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.
This study investigates the prevalence, causes, and demographic characteristics of patients seeking visual impairment certificates at Assiut Ophthalmology Hospital. Using a prospective cross-sectional design, it aims to identify the magnitude and nature of visual impairment in this population by analyzing clinical data, performing comprehensive eye examinations, and utilizing advanced diagnostic tools.
Detailed description
The study is designed to explore the prevalence, underlying causes, and demographic profiles of patients requesting visual impairment certificates at Assiut Ophthalmology Hospital. It employs a prospective cross-sectional approach, recruiting patients from ophthalmology outpatient clinics who meet the World Health Organization's (WHO) definition of blindness. Blindness is defined as having best-corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10° or less in the widest diameter of vision.
Eligible participants undergo comprehensive eye examinations, including visual acuity measurement using Snellen charts, slit-lamp biomicroscopy, dilated fundus examination, and automated perimetry for visual field assessment. Advanced investigations such as OCT macula imaging, VEP (visual evoked potential), ERG (electroretinography), ultrasound, and fundus photography are performed to identify the causes of visual impairment. Demographic data-such as age, sex, marital status, occupation, socioeconomic status, education level-and systemic medical history are collected to assess contributing factors.
The sample size was calculated using Epi-info software with a confidence level of 95% and confidence limits of 5%, estimating a minimum of 383 cases. By analyzing clinical findings alongside demographic characteristics, the study aims to provide valuable insights into the magnitude and nature of visual impairment in this specific population. This information could help inform public health strategies and improve services for visually impaired individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Seeking Visual Impairment Certificates at Assiut Ophthalmology Hospital | – | –The study population consists of patients requesting visual impairment certificates at Assiut Ophthalmology Hospital, who have undergone all required investigations, including visual field testing, OCT macula imaging, VEP, ERG, ultrasound, and fundus photography. Eligible participants are those fulfilling WHO's definition of blindness, defined as having best-corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10° or less in the widest diameter of vision. Excluded are patients unwilling to participate or with incomplete/missing investigations. A calculated sample size of 383 cases ensures statistical reliability. Demographic and clinical data such as age, sex, occupation, socioeconomic status, marital status, education level, and associated systemic conditions are collected alongside comprehensive eye examinations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants undergo comprehensive eye examinations, including visual acuity measurement using Snellen charts, slit-lamp biomicroscopy, dilated fundus examination, and automated perimetry for visual field assessment. Advanced investigations such as OCT macula imaging, VEP (visual evoked potential), ERG (electroretinography), ultrasound, and fundus photography are performed to identify the causes of visual impairment. Demographic data-such as age, sex, marital status, occupation, socioeconomic status, education level-and systemic medical history are collected to assess contributing factors.
Key inclusion criteria (1 listed)
- Patients requesting visual impairment certificate at Assiut ophthalmology hospital having all investigations Visual field, OCT macula, VEP, ERG, US, Fundus photography Werepatients who fulfilled WHO's definition of blindness. The blind patients according to WHO's,were defined as patients having best corrected distance visual acuity (BCVA) of 3/60 or less in the better eye or a visual field restricted to 10 or less in the widest diameter of vision.
Key exclusion criteria (1 listed)
- Patients unwilling to participate in the study Incomplete or missing investigations
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
BCVA
Time frame: 1 month
BCVA of 3/60 or less in the better eye visual field restricted to 10 or less in the widest diameter of vision.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- BackgroundInternational Journal of Research in Medical Sciences Priya M et al. Int J Res Med Sci. 2023 Aug
- BackgroundBourne et al. (2013). Prevalence and causes of vision loss in high-income countries: a review. Lancet Global Health
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Demographic Profiles and Impairment Certificates, run by Assiut 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 1 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: opening soon, as of the sponsor's last update on 28 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06900855, which also lists 2 linked publications.
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 28 Mar 2025.