Patients Seeking a Visual Impairment Certificate

March 22, 2025 updated by: Madona Gerges Boles, Assiut University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients unwilling to participate in the study Incomplete or missing investigations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • visual impairment certificate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Visual Impairment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings