CClinicalTrials.gg
Not yet recruitingNCT06900855Updated Mar 28, 2025

Patients Seeking a Visual Impairment Certificate

An observational study in Demographic Profiles, Impairment Certificates and Visual Impairment, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
383
Sex
All
01

Study 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 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.

02

Conditions studied

  • Demographic Profiles
  • Impairment Certificates
  • Visual Impairment

Keywords

  • visual impairment
  • demographic profiles
  • visual impairment certificates
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Patients unwilling to participate in the study Incomplete or missing investigations
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
383 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. BCVA

    BCVA of 3/60 or less in the better eye visual field restricted to 10 or less in the widest diameter of vision.

    Time frame: 1 month

06

Study locations

No study locations are listed for this record.

07

References and documents

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

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06900855
Lead sponsor
Assiut University
Responsible party
Madona Gerges Boles (resident at Ophthalmology department, Assiut University) — Principal investigator
First posted
Mar 28, 2025
Start date
May 1, 2025 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Mar 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion