Intellectual DisabilityNCT06737627
Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability
An observational study of Intellectual Disability, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- How many people
- 1,400 participants
- Where
- 2 sitesTaiwan
- Study dates
- 9 Apr 2024to 31 Dec 2027
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intellectual disability
Who may be able to join
- Age 20 and above
- Primary caregivers for at least one adult with ID (have disability identification or (and) certification).
Who cannot join
- Unable to communicate in Mandarin or Taiwanese.(Primarycaregivers)
- Unable to cooperate with eye examination.(ID)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Care facility
New Taipei City
Chiun-Ho Hou, +8863123456 ext. 274253, chiunhohou@gmail.com
- Recruiting
Care facility
Taipei
Chiun-Ho Hou, +8863123456 ext. 274253, chiunhohou@gmail.com
About this study
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.
Read more
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:
- To develop an item bank of ocular conditions of adults with ID;
- 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.
- Conditions
- Intellectual Disability
- Being tested
- no intervention
- Keywords
- Intellectual disability, Adults, Visual Scale, Caregiver
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Intellectual disability | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Socioeconomic Data for Individuals with Disabilities
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.
Measured: 1-3 months
Assessment Scales for Individuals with Disabilities
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.
Measured: 1-3 months
Ophthalmologic Examination Form
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.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start9 Apr 2024
- Primary completion29 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737627
- Sponsor's protocol ID
- 202212036RINA
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability
- ClinicalTrials.gov ID
- NCT06737627
- Acronym / sponsor ID
- 202212036RINA
- Conditions
- Intellectual Disability
- Keywords
- Intellectual disability, Adults, Visual Scale, Caregiver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2024 (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.
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:
- To develop an item bank of ocular conditions of adults with ID;
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intellectual disability | – | Other: no intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intellectual disability
Key inclusion criteria (2 listed)
- Age 20 and above
- Primary caregivers for at least one adult with ID (have disability identification or (and) certification).
Key exclusion criteria (2 listed)
- Unable to communicate in Mandarin or Taiwanese.(Primarycaregivers)
- Unable to cooperate with eye examination.(ID)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Intellectual disability |
Primary outcome
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.
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.
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.
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 24 Apr 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Chiun-Ho Hou, Ph.D (+88623123456 ext. 262131, chiunhohou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Socioeconomic Data for Individuals with Disabilities (time frame: 1-3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.