Vision DisorderNCT07858708
Visual Impairment and Functional Visual Performance Following Acquired Brain Injury: A Cross-Sectional Study
An observational study of Vision Disorder and Stroke, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
This cross-sectional observational study aims to characterize acquired visual impairment in adults with acquired brain injury and to examine the relationship between objectively identified visual impairment and self-reported functional visual performance. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vision Disorder, Stroke, Brain Injuries
- How many people
- 108 participants
- Where
- 1 siteCzechia
- Study dates
- Oct 2026to Feb 2029
- How long will I take part?
- 1 Day
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults with acquired brain injury receiving inpatient or outpatient rehabilitation and neurological care at multiple clinical sites in the Czech Republic. Participants will be recruited from patients referred for rehabilitation assessment and treatment at participating healthcare facilities. The study population will include individuals with stroke, traumatic brain injury, and brain tumors at different stages of recovery.
Who may be able to join
- Adults aged 18-85 years.
- Diagnosis of acquired brain injury, including stroke, traumatic brain injury, or brain tumor.
- Ability to participate in the required study assessment.
- Ability to understand the study procedures and provide informed consent.
Who cannot join
- Pre-existing ocular or visual disorder of sufficient severity to prevent valid assessment of study visual outcomes or to preclude attribution of the identified impairment to acquired brain injury.
- Severe communication impairment preventing reliable completion of the required study assessments.
- Medical, neurological, behavioral, or other condition preventing reliable completion of the required study assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
General University Hospital in Prague, 1. Faculty of Medicine, Charles University
Prague, Česká Republika, 12808
About this study
Official title: Objective Visual Impairment and Self-Reported Functional Visual Performance Following Acquired Brain Injury: A Cross-Sectional Observational Study
This cross-sectional observational study aims to characterize acquired visual impairment in adults with acquired brain injury and to examine the relationship between objectively identified visual impairment and self-reported functional visual performance.
A total of 108 adults with acquired brain injury, including stroke, traumatic brain injury, and brain tumor, will undergo a standardized visual assessment. Objective visual function will be evaluated across five predefined domains: visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. Self-reported functional visual performance will be assessed using the Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP).
The study will determine the proportion of participants with objectively identified visual impairment and examine the association between the R-SRAFVP score and the number of objectively impaired visual domains. The distribution of impairment across the individual visual domains will also be described.
Read the detailed description
Visual impairment following acquired brain injury may involve multiple aspects of visual function, including visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention. The relationship between objectively identified visual impairment and an individual's self-reported functional visual performance following acquired brain injury remains clinically relevant to characterize.
This cross-sectional observational study will characterize objectively identified visual impairment and self-reported functional visual performance in 108 adults with acquired brain injury, including stroke, traumatic brain injury, and brain tumor.
Participants will be recruited consecutively from eligible patients receiving inpatient or outpatient neurological or rehabilitation care at participating clinical sites. Each participant will undergo a single standardized study assessment.
Objective visual function will be evaluated across five predefined domains: visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. Each domain will be classified as impaired or not impaired according to prespecified study criteria based on the corresponding visual assessment measures. The number of objectively impaired visual domains will be summarized using a study-derived count ranging from 0 to 5. This count does not represent a standardized composite score of any individual visual assessment instrument.
Self-reported functional visual performance will be assessed using the 33-item Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP). The R-SRAFVP score will be calculated according to the scoring procedure of the current assessment, which accounts for items rated as not applicable. Higher item ratings indicate greater independence and less difficulty in vision-dependent activities of daily living.
The primary objectives are to determine the proportion of participants with objectively identified visual impairment and to examine the association between the R-SRAFVP score and the number of objectively impaired visual domains. The proportion of participants with impairment in each individual visual domain will additionally be described.
- Conditions
- Vision Disorder, Stroke, Brain Injuries
- Keywords
- Acquired Brain Injury, Visual Impairment, Vision, Stroke, Visual Function, Occupational Therapy
- Medical subject headings
- Vision Disorders, Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Acquired Brain Injury | Adults with acquired brain injury, including stroke, traumatic brain injury, and brain tumor, undergoing a single standardized assessment of objective visual function and self-reported functional visual performance. Participants are not assigned to an intervention as part of this observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with objectively identified visual impairment
Proportion of participants with at least one objectively identified impairment across the five predefined visual domains: visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. Each domain will be classified as impaired or not impaired according to prespecified study criteria based on the corresponding visual assessment measures. A participant will be classified as having objectively identified visual impairment if impairment is identified in at least one of the five domains. The outcome will be reported as the number and percentage of participants meeting this definition.
Measured: Baseline (single assessment)
Association between R-SRAFVP score and number of objectively impaired visual domains
Association between self-reported functional visual performance assessed using the 33-item Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP) and the extent of objectively identified visual impairment. The R-SRAFVP score will be calculated according to the scoring procedure of the current assessment, which accounts for items rated as not applicable; higher item ratings indicate greater independence and less difficulty in vision-dependent activities of daily living. Objective visual impairment will be summarized as a study-derived count ranging from 0 to 5, representing the number of impaired domains among visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. The association between the R-SRAFVP score and the number of objectively impaired visual domains will be evaluated.
Measured: Baseline (single assessment)
Secondary outcomes (1)
Proportion of participants with objectively identified impairment in each visual domain
Proportion of participants with objectively identified impairment in each of the five predefined visual domains: visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. Each domain will be classified as impaired or not impaired according to prespecified study criteria based on the corresponding visual assessment measures. Results will be reported separately for each domain as the number and percentage of participants classified as impaired.
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion18 Sep 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisorderStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858708
- Sponsor's protocol ID
- 506225 - OBS
- Other IDs
- 506225 GAUK
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be made publicly available or shared with other researchers. Study results will be disseminated in aggregated and de-identified form through scientific publications and presentations. No individual participant data sharing plan has been established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Visual Impairment and Self-Reported Functional Visual Performance Following Acquired Brain Injury: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07858708
- Acronym / sponsor ID
- 506225 - OBS
- Conditions
- Vision Disorder, Stroke, Brain Injuries
- Keywords
- Acquired Brain Injury, Visual Impairment, Vision, Stroke, Visual Function, Occupational Therapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- Oct 2026 (estimated)
- Primary completion
- 18 Sep 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 5 Oct 2026 (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.
This cross-sectional observational study aims to characterize acquired visual impairment in adults with acquired brain injury and to examine the relationship between objectively identified visual impairment and self-reported functional visual performance.
A total of 108 adults with acquired brain injury, including stroke, traumatic brain injury, and brain tumor, will undergo a standardized visual assessment. Objective visual function will be evaluated across five predefined domains: visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. Self-reported functional visual performance will be assessed using the Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP).
The study will determine the proportion of participants with objectively identified visual impairment and examine the association between the R-SRAFVP score and the number of objectively impaired visual domains. The distribution of impairment across the individual visual domains will also be described.
Detailed description
Visual impairment following acquired brain injury may involve multiple aspects of visual function, including visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention. The relationship between objectively identified visual impairment and an individual's self-reported functional visual performance following acquired brain injury remains clinically relevant to characterize.
This cross-sectional observational study will characterize objectively identified visual impairment and self-reported functional visual performance in 108 adults with acquired brain injury, including stroke, traumatic brain injury, and brain tumor.
Participants will be recruited consecutively from eligible patients receiving inpatient or outpatient neurological or rehabilitation care at participating clinical sites. Each participant will undergo a single standardized study assessment.
Objective visual function will be evaluated across five predefined domains: visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. Each domain will be classified as impaired or not impaired according to prespecified study criteria based on the corresponding visual assessment measures. The number of objectively impaired visual domains will be summarized using a study-derived count ranging from 0 to 5. This count does not represent a standardized composite score of any individual visual assessment instrument.
Self-reported functional visual performance will be assessed using the 33-item Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP). The R-SRAFVP score will be calculated according to the scoring procedure of the current assessment, which accounts for items rated as not applicable. Higher item ratings indicate greater independence and less difficulty in vision-dependent activities of daily living.
The primary objectives are to determine the proportion of participants with objectively identified visual impairment and to examine the association between the R-SRAFVP score and the number of objectively impaired visual domains. The proportion of participants with impairment in each individual visual domain will additionally be described.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Acquired Brain Injury | – | –Adults with acquired brain injury, including stroke, traumatic brain injury, and brain tumor, undergoing a single standardized assessment of objective visual function and self-reported functional visual performance. Participants are not assigned to an intervention as part of this observational study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults with acquired brain injury receiving inpatient or outpatient rehabilitation and neurological care at multiple clinical sites in the Czech Republic. Participants will be recruited from patients referred for rehabilitation assessment and treatment at participating healthcare facilities. The study population will include individuals with stroke, traumatic brain injury, and brain tumors at different stages of recovery.
Key inclusion criteria (4 listed)
- Adults aged 18-85 years.
- Diagnosis of acquired brain injury, including stroke, traumatic brain injury, or brain tumor.
- Ability to participate in the required study assessment.
- Ability to understand the study procedures and provide informed consent.
Key exclusion criteria (3 listed)
- Pre-existing ocular or visual disorder of sufficient severity to prevent valid assessment of study visual outcomes or to preclude attribution of the identified impairment to acquired brain injury.
- Severe communication impairment preventing reliable completion of the required study assessments.
- Medical, neurological, behavioral, or other condition preventing reliable completion of the required study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with objectively identified visual impairment
Time frame: Baseline (single assessment)
Proportion of participants with at least one objectively identified impairment across the five predefined visual domains: visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. Each domain will be classified as impaired or not impaired according to prespecified study criteria based on the corresponding visual assessment measures. A participant will be classified as having objectively identified visual impairment if impairment is identified in at least one of the five domains. The outcome will be reported as the number and percentage of participants meeting this definition.
Association between R-SRAFVP score and number of objectively impaired visual domains
Time frame: Baseline (single assessment)
Association between self-reported functional visual performance assessed using the 33-item Revised Self-Report Assessment of Functional Visual Performance (R-SRAFVP) and the extent of objectively identified visual impairment. The R-SRAFVP score will be calculated according to the scoring procedure of the current assessment, which accounts for items rated as not applicable; higher item ratings indicate greater independence and less difficulty in vision-dependent activities of daily living. Objective visual impairment will be summarized as a study-derived count ranging from 0 to 5, representing the number of impaired domains among visual acuity, contrast sensitivity, visual field, oculomotor function, and visual attention/scanning. The association between the R-SRAFVP score and the number of objectively impaired visual domains will be evaluated.
1 secondary outcome
Proportion of participants with objectively identified impairment in each visual domain
Time frame: Baseline (single assessment)
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 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be made publicly available or shared with other researchers. Study results will be disseminated in aggregated and de-identified form through scientific publications and presentations. No individual participant data sharing plan has been established for this study.
Related trials for Vision Disorder
Not yet recruitingPhase 2
A Phase 2 Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis
Blepharitis
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Disorder and Stroke, run by Charles University, Czech Republic at 1 site in Czechia.
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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with objectively identified visual impairment (time frame: Baseline (single assessment)). The study lists 2 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 5 Oct 2026.