Patients Seeking a Visual Impairment Certificate

NCT ID: NCT06900855

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 383 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-08-30

Brief 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.

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.

Conditions

Demographic Profiles; Impairment Certificates; Visual Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Madona Gerges Boles

resident at Ophthalmology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

International Journal of Research in Medical Sciences Priya M et al. Int J Res Med Sci. 2023 Aug

Reference Type: BACKGROUND

Bourne et al. (2013). Prevalence and causes of vision loss in high-income countries: a review. Lancet Global Health

Reference Type: BACKGROUND

Other Identifiers

visual impairment certificate

Identifier Type: -

Identifier Source: org_study_id