Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability

April 21, 2026 updated by: National Taiwan University Hospital

Background:

Around 15% of the global population has some form of disability. Rights to obtain proper health care is an emphasis in the United Nationals Convention on the Right of People with Disability. Due to the importance of improving vision health for people with disabilities, studies on how to identify vision problems becomes extremely important in policy formulation for all countries. Among all types of disabilities, people with intellectual disability (ID) are among the ones where vision problems are the hardest to detect.

Currently, no caregiver assessable scales are available, as a result, adults with ID are at high risk of delayed diagnose for common ocular conditions. Objectives: This is a one-year project.

The objective of this study is two folds:

  1. To develop an item bank of ocular conditions of adults with ID;
  2. To develop a scale for caregivers to detect ocular conditions for adults with ID, and to validate the reliability, construct validity and responsiveness of the scale.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Care facility
        • Contact:
      • Taipei, Taiwan
        • Recruiting
        • Care facility
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Intellectual disability

Description

Inclusion Criteria:

  1. Age 20 and above
  2. Primary caregivers for at least one adult with ID (have disability identification or (and) certification).

Exclusion Criteria:

  1. Unable to communicate in Mandarin or Taiwanese.(Primarycaregivers)
  2. Unable to cooperate with eye examination.(ID)

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
Intervention / Treatment
Intellectual disability
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of Socioeconomic Data for Individuals with Disabilities
Time Frame: 1-3 months
This study collects basic socioeconomic data of individuals with disabilities through tailored questionnaires, including gender, date of birth, educational background, living conditions, and employment status. The questionnaire is designed to accommodate the specific characteristics of individuals with intellectual disabilities and is completed by respondents or their proxies. These data will be analyzed to understand the impact of socioeconomic factors on the visual health and accessibility to medical services for people with disabilities. Ethical guidelines are strictly followed to ensure confidentiality and protect participant rights.
1-3 months
Assessment Scales for Individuals with Disabilities
Time Frame: 1-3 months
This study utilizes validated assessment tools to evaluate the visual functions and daily living abilities of individuals with disabilities. These include the Activities of Daily Living (ADL) Scale and Instrumental Activities of Daily Living (IADL) Scale, supplemented by specific observational items for visual health and related functional behaviors. The scales employ a graded scoring system covering personal hygiene, mobility, social interaction, and visual challenges. The collected data will help analyze the impact of visual impairment on independent living skills and support the development of tailored visual intervention strategies. Participant privacy and ethical compliance are rigorously maintained.
1-3 months
Ophthalmologic Examination Form
Time Frame: 1-3 months
A standardized ophthalmologic examination form is employed in this study to record detailed visual and eye health data of individuals with disabilities. The form includes uncorrected and corrected visual acuity, intraocular pressure, eye movement, corneal conditions, iris, macula, retina, and other ocular components. It also documents spherical power, cylindrical power, and axis to assess refractive correction needs. The form provides a section for medical recommendations such as eyeglass prescription, medical referral, or regular follow-up. These comprehensive data support analysis of visual problems' effects on individuals and guide the formulation of personalized visual intervention plans.
1-3 months

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

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 (Actual)

April 9, 2024

Primary Completion (Estimated)

January 29, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202212036RINA

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.

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