SchizophreniaVRiSNCT03314129
Remediation of Visual Perceptual Impairments in People With Schizophrenia
A study testing UltimEyes, Contour Integration Training and UltimEyes + Contour Integration Training in people with Schizophrenia and Schizoaffective Disorder, run by University of Rochester at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two visual functions that much research has shown are impaired in many people with the disorder, namely contrast sensitivity and perceptual organization. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- UltimEyes, Contour Integration Training and UltimEyes + Contour Integration Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- SCID-5 diagnosis of schizophrenia;
- 18-60 years old;
- speaks English;
- able to complete the MATRICS Consensus Cognitive Battery (MCCB) at the baseline assessment (for R33);
- a raw score of 37 or greater on the Wide Range Achievement Test, Reading subtest (WRAT-3), to establish a minimum reading level (6th grade) and to estimate premorbid IQ; and
- clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.
Who cannot join
- history of intellectual disability, or developmental or neurological disorder;
- history of brain trauma associated with loss of consciousness for > 10 minutes or behavioral sequelae;
- alcohol or substance use disorder within the last 6 months; and
- history of eye disease (e.g., glaucoma, retinopathy).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Rochester Medical Center - Strong Ties Community Support Clinic
Rochester, New York, 14623
New York Presbyterian Hospital
White Plains, New York, 10605
About this study
Official title: Visual Remediation in Schizophrenia
The purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two visual functions that much research has shown are impaired in many people with the disorder, namely contrast sensitivity and perceptual organization. The first phase of the study will test the effects of interventions targeting each of these processes, as well as the effects of a combined package. A control condition of higher-level cognitive remediation is included as a fourth condition. The second phase of the study will evaluate the effectiveness of the most effective intervention from the first phase, but in a new and larger sample of individuals. Outcome measures include multiple aspects of visual functioning, as well as visual cognition and overall community functioning.
Read the detailed description
It is increasingly clear that people with schizophrenia have a range of visual perception impairments, including in low-level vision (e.g., acuity, contrast sensitivity) and mid-level vision (e.g., perceptual organization, coherent motion detection). These impairments are significantly related to poorer performance on cognitive (e.g., visual learning and memory) and social cognitive (e.g., facial emotion decoding) measures, and to worse functional outcomes. To date, there is no accepted technique for visual remediation for schizophrenia, and almost no work has been done in this area. However, visual remediation is a well-developed subfield within cognitive rehabilitation for traumatic brain injury (TBI) patients, and initial studies of short-term visual perceptual learning in schizophrenia indicate that plasticity exists that could support longer-term changes. Therefore, the overall goal of the proposed project is to test a visual remediation intervention for schizophrenia and determine its effects on specific visual targets with well-understood neurobiological mechanisms. The goal of the R61 is to determine the optimal intervention for improving the targets of contrast sensitivity (CS) and perceptual organization (PO). Extensive evidence exists for impaired CS and PO in schizophrenia. Moreover, these targets are prototypical examples of gain control and integration, respectively, which were identified by the NIMH-sponsored CNTRICS initiative as being the two core mechanisms involved in visual disturbances in the disorder. The investigators will examine two computer-based interventions. One, ULTIMEYES (UE), targets CS. The other, contour integration training (CIT), targets PO. The investigators will also examine the effects of combined treatment (UE\&CIT). An active computer-based control treatment will be included. There will be 40 sessions, with assessments after every 10 sessions (N=20/group). The R61 Specific Aim is to evaluate the effects of UE and CIT on CS and PO targets, respectively, to determine if treatment effects meet a pre-specified effect-size criterion. Results of the R61 will be used to identify the treatment (UE, CIT, or UE\&CIT) and duration (i.e., dose) that most effectively and efficiently improves the target(s). The goal of the R33 is to conduct an initial randomized controlled trial (RCT) of the optimal treatment identified in the R61. The R33 Specific Aims are to: 1) replicate and extend R61 results supporting visual target engagement in an adequately powered RCT (N=50/group); and 2) determine if visual target engagement is associated with improvements in cognition, social cognition, and functional capacity. If the R33 hypotheses are confirmed, results will inform the design of a later RCT to further explore mediators and moderators of treatment effects, and to move towards a precision medicine approach, wherein we determine which individuals are most likely to benefit from this intervention.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- UltimEyes, Contour Integration Training, UltimEyes + Contour Integration Training, MyBrainSolutions
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltimEyesBehavioural
A computer program developed to improve contrast sensitivity and visual acuity.
Contour Integration TrainingBehavioural
A computerized program to improve contour integration (a form of perceptual organization).
UltimEyes + Contour Integration TrainingBehavioural
The combination of UltimEyes and Contour Integration Training
MyBrainSolutionsBehavioural
A computer program consisting of exercises to improve cognition (attention, memory, planning) and to facilitate goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Contrast sensitivity | Experimental | UltimEyes Receives: Behavioral: UltimEyes |
| Perceptual organization | Experimental | Contour Integration Training Receives: Behavioral: Contour Integration Training |
| Contrast sensitivity + Perceptual org. | Experimental | UltimEyes + Contour Integration Training Receives: Behavioral: UltimEyes + Contour Integration Training |
| Cognitive remediation | Active comparator | MyBrainSolutions Receives: Behavioral: MyBrainSolutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast sensitivity - behavioral
Peak contrast, as measures by a behavioral (psychophysical) measure of contrast sensitivity.
Measured: Years 1-5
Contrast sensitivity - electrophysiological
Steady state visual evoked potential (ssVEP) amplitudes recorded during the contrast sensitivity task.
Measured: Years 1-5
Contour integration
Total score on the Jittered-Orientation Visual Integration Task, or JOVI), a psychophysical measure of perceptual organization.
Measured: Years 1-5
Secondary outcomes (4)
Reading speed
Minnesota Low-Vision Reading Test (MNREAD): This test assesses reading speed ability. The charts contain 19 English sentences (60 characters each) with print sizes ranging from 1.3 to -0.5 logMAR at a distance of 16 inches (0.41 meters).
Measured: Years 3-5
Emotion recognition
Total score on the Penn Emotion Recognition Test, a computerized test of emotion recognition.
Measured: Years 3-5
Cognition
Total score on the MATRICS Consensus Cognitive Battery
Measured: Years 3-5
Community functioning
Total score on the UCSD Performance-Based Skills Assessment (UPSA), a test of the ability to perform various skills important in residential and community settings.
Measured: Years 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 Jun 2018
- Primary completion31 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, Weill Medical College of Cornell University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Steven Silverstein, University of Rochester
- Investigators
- Steven M Silverstein, Ph.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314129
- Sponsor's protocol ID
- 20170000922
- Other IDs
- R61MH115119
- Acronym
- VRiS
- Status last verified
- Sep 2025
- First submitted
- 4 Oct 2017
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silverstein SM, Seitz AR, Ahmed AO, Thompson JL, Zemon V, Gara M, Butler PD. Development and Evaluation of a Visual Remediation Intervention for People with Schizophrenia. J Psychiatr Brain Sci. 2020;5:e200017. doi: 10.20900/jpbs.20200017. Epub 2020 Jul 20.
PubMed 32789191Butler PD, Thompson JL, Seitz AR, Deveau J, Silverstein SM. Visual perceptual remediation for individuals with schizophrenia: Rationale, method, and three case studies. Psychiatr Rehabil J. 2017 Mar;40(1):43-52. doi: 10.1037/prj0000212. Epub 2016 Aug 22.
PubMed 27547852
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Remediation in Schizophrenia
- ClinicalTrials.gov ID
- NCT03314129
- Acronym / sponsor ID
- VRiS / 20170000922
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- New York University, Weill Medical College of Cornell University, National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 19 Oct 2017 (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.
The purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two visual functions that much research has shown are impaired in many people with the disorder, namely contrast sensitivity and perceptual organization. The first phase of the study will test the effects of interventions targeting each of these processes, as well as the effects of a combined package. A control condition of higher-level cognitive remediation is included as a fourth condition. The second phase of the study will evaluate the effectiveness of the most effective intervention from the first phase, but in a new and larger sample of individuals. Outcome measures include multiple aspects of visual functioning, as well as visual cognition and overall community functioning.
Detailed description
It is increasingly clear that people with schizophrenia have a range of visual perception impairments, including in low-level vision (e.g., acuity, contrast sensitivity) and mid-level vision (e.g., perceptual organization, coherent motion detection). These impairments are significantly related to poorer performance on cognitive (e.g., visual learning and memory) and social cognitive (e.g., facial emotion decoding) measures, and to worse functional outcomes. To date, there is no accepted technique for visual remediation for schizophrenia, and almost no work has been done in this area. However, visual remediation is a well-developed subfield within cognitive rehabilitation for traumatic brain injury (TBI) patients, and initial studies of short-term visual perceptual learning in schizophrenia indicate that plasticity exists that could support longer-term changes. Therefore, the overall goal of the proposed project is to test a visual remediation intervention for schizophrenia and determine its effects on specific visual targets with well-understood neurobiological mechanisms. The goal of the R61 is to determine the optimal intervention for improving the targets of contrast sensitivity (CS) and perceptual organization (PO). Extensive evidence exists for impaired CS and PO in schizophrenia. Moreover, these targets are prototypical examples of gain control and integration, respectively, which were identified by the NIMH-sponsored CNTRICS initiative as being the two core mechanisms involved in visual disturbances in the disorder. The investigators will examine two computer-based interventions. One, ULTIMEYES (UE), targets CS. The other, contour integration training (CIT), targets PO. The investigators will also examine the effects of combined treatment (UE\&CIT). An active computer-based control treatment will be included. There will be 40 sessions, with assessments after every 10 sessions (N=20/group). The R61 Specific Aim is to evaluate the effects of UE and CIT on CS and PO targets, respectively, to determine if treatment effects meet a pre-specified effect-size criterion. Results of the R61 will be used to identify the treatment (UE, CIT, or UE\&CIT) and duration (i.e., dose) that most effectively and efficiently improves the target(s). The goal of the R33 is to conduct an initial randomized controlled trial (RCT) of the optimal treatment identified in the R61. The R33 Specific Aims are to: 1) replicate and extend R61 results supporting visual target engagement in an adequately powered RCT (N=50/group); and 2) determine if visual target engagement is associated with improvements in cognition, social cognition, and functional capacity. If the R33 hypotheses are confirmed, results will inform the design of a later RCT to further explore mediators and moderators of treatment effects, and to move towards a precision medicine approach, wherein we determine which individuals are most likely to benefit from this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Contrast sensitivity | Experimental | Behavioral: UltimEyesUltimEyes |
| Perceptual organization | Experimental | Behavioral: Contour Integration TrainingContour Integration Training |
| Contrast sensitivity + Perceptual org. | Experimental | Behavioral: UltimEyes + Contour Integration TrainingUltimEyes + Contour Integration Training |
| Cognitive remediation | Active comparator | Behavioral: MyBrainSolutionsMyBrainSolutions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- SCID-5 diagnosis of schizophrenia;
- 18-60 years old;
- speaks English;
- able to complete the MATRICS Consensus Cognitive Battery (MCCB) at the baseline assessment (for R33);
- a raw score of 37 or greater on the Wide Range Achievement Test, Reading subtest (WRAT-3), to establish a minimum reading level (6th grade) and to estimate premorbid IQ; and
Key exclusion criteria (4 listed)
- history of intellectual disability, or developmental or neurological disorder;
- history of brain trauma associated with loss of consciousness for > 10 minutes or behavioral sequelae;
- alcohol or substance use disorder within the last 6 months; and
- history of eye disease (e.g., glaucoma, retinopathy).
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 |
|---|---|---|
| UltimEyesA computer program developed to improve contrast sensitivity and visual acuity. | Behavioural | Contrast sensitivity |
| Contour Integration TrainingA computerized program to improve contour integration (a form of perceptual organization). | Behavioural | Perceptual organization |
| UltimEyes + Contour Integration TrainingThe combination of UltimEyes and Contour Integration Training | Behavioural | Contrast sensitivity + Perceptual org. |
| MyBrainSolutionsA computer program consisting of exercises to improve cognition (attention, memory, planning) and to facilitate goal setting. | Behavioural | Cognitive remediation |
Primary outcome
Contrast sensitivity - behavioral
Time frame: Years 1-5
Peak contrast, as measures by a behavioral (psychophysical) measure of contrast sensitivity.
Contrast sensitivity - electrophysiological
Time frame: Years 1-5
Steady state visual evoked potential (ssVEP) amplitudes recorded during the contrast sensitivity task.
Contour integration
Time frame: Years 1-5
Total score on the Jittered-Orientation Visual Integration Task, or JOVI), a psychophysical measure of perceptual organization.
4 secondary outcomes
Reading speed
Time frame: Years 3-5
Emotion recognition
Time frame: Years 3-5
Cognition
Time frame: Years 3-5
Community functioning
Time frame: Years 3-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 32789191Silverstein SM, Seitz AR, Ahmed AO, Thompson JL, Zemon V, Gara M, Butler PD. Development and Evaluation of a Visual Remediation Intervention for People with Schizophrenia. J Psychiatr Brain Sci. 2020;5:e200017. doi: 10.20900/jpbs.20200017. Epub 2020 Jul 20.
- Results publication: PubMed 27547852Butler PD, Thompson JL, Seitz AR, Deveau J, Silverstein SM. Visual perceptual remediation for individuals with schizophrenia: Rationale, method, and three case studies. Psychiatr Rehabil J. 2017 Mar;40(1):43-52. doi: 10.1037/prj0000212. Epub 2016 Aug 22.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Steven M Silverstein, Ph.D. principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltimEyes, Contour Integration Training and UltimEyes + Contour Integration Training in people with Schizophrenia and Schizoaffective Disorder, run by University of Rochester at 2 sites in United States.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 Sep 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Contrast sensitivity - behavioral (time frame: Years 1-5). 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?
On the ClinicalTrials.gov record for NCT03314129, which also lists 2 linked publications.
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 Sep 2025.