NCT03314129

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

6.8 years

First QC Date

October 4, 2017

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Contrast sensitivity - behavioral

    Peak contrast, as measures by a behavioral (psychophysical) measure of contrast sensitivity.

    Years 1-5

  • Contrast sensitivity - electrophysiological

    Steady state visual evoked potential (ssVEP) amplitudes recorded during the contrast sensitivity task.

    Years 1-5

  • Contour integration

    Total score on the Jittered-Orientation Visual Integration Task, or JOVI), a psychophysical measure of perceptual organization.

    Years 1-5

Secondary Outcomes (4)

  • Reading speed

    Years 3-5

  • Emotion recognition

    Years 3-5

  • Cognition

    Years 3-5

  • Community functioning

    Years 3-5

Study Arms (4)

Contrast sensitivity

EXPERIMENTAL

UltimEyes

Behavioral: UltimEyes

Perceptual organization

EXPERIMENTAL

Contour Integration Training

Behavioral: Contour Integration Training

Contrast sensitivity + Perceptual org.

EXPERIMENTAL

UltimEyes + Contour Integration Training

Behavioral: UltimEyes + Contour Integration Training

Cognitive remediation

ACTIVE COMPARATOR

MyBrainSolutions

Behavioral: MyBrainSolutions

Interventions

UltimEyesBEHAVIORAL

A computer program developed to improve contrast sensitivity and visual acuity.

Contrast sensitivity

A computerized program to improve contour integration (a form of perceptual organization).

Perceptual organization

The combination of UltimEyes and Contour Integration Training

Contrast sensitivity + Perceptual org.

A computer program consisting of exercises to improve cognition (attention, memory, planning) and to facilitate goal setting.

Cognitive remediation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • SCID-5 diagnosis of schizophrenia;
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Rochester Medical Center - Strong Ties Community Support Clinic

Rochester, New York, 14623, United States

Location

New York Presbyterian Hospital

White Plains, New York, 10605, United States

Location

Related Publications (2)

  • 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.

    PMID: 32789191BACKGROUND
  • Butler 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.

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Steven M Silverstein, Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 19, 2017

Study Start

June 1, 2018

Primary Completion

March 31, 2025

Study Completion

May 31, 2025

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations