An interventional study of Training in the blind field and Training in the intact field in Stroke Induced Vision Loss, Hemianopia and Quadrantanopia, sponsored by University of Rochester. Completed at 3 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
The purpose of this research is to assess the efficacy of a visual training task on reducing the size of a visual field deficit caused by brain damage in adults, and its ability to improve visual functions in this patient population.
63 studies on the registry are indexed under Hemianopsia; 24 are open to participants now.
This study's enrollment of 48 is above the median of 32 across 53 interventional studies indexed under Hemianopsia.
Browse Hemianopsia studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Training in the blind field using software
Device: Training in the blind field
Training in the intact field using software
Device: Training in the intact field
A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint
Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval.
Time frame: 6 months
| Milestone | Training in the Blind Field | Training in the Intact Field |
|---|---|---|
| Started | 25 | 23 |
| Completed | 23 | 23 |
| Not completed | 2 | 0 |
Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval.
| decibels | Training in the Blind Field (Left Eye) | Training in the Intact Field (Left Eye) | Training in the Blind Field (Right Eye) | Training in the Intact Field (Right Eye) |
|---|---|---|---|---|
| 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint | 0.84 (0.22 to 1.47) | 0.10 (-0.52 to 0.72) | 0.58 (0.07 to 1.08) | 0.12 (-0.38 to 0.62) |
Collected over Adverse event data were collected between initial enrollment and the conclusion of final assessment. For a given subject this period covered approximately 6 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Training in the Blind Field | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Training in the Intact Field | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | Training in the Blind Field | Training in the Intact Field | Total |
|---|---|---|---|
| Mean | 57.4 ± 10.8 | 61.5 ± 9.4 | 59.3 ± 10.5 |
| Sex: Female, Male(Participants) | Training in the Blind Field | Training in the Intact Field | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 19 | 18 | 37 |
| Race (NIH/OMB)(Participants) | Training in the Blind Field | Training in the Intact Field | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 25 | 23 | 48 |
| Region of Enrollment(participants) | Training in the Blind Field | Training in the Intact Field | Total |
|---|---|---|---|
| United States | 25 | 23 | 48 |
| Preliminary deficit size(square degrees of visual angle) | Training in the Blind Field | Training in the Intact Field | Total |
|---|---|---|---|
| Mean | 819.7 ± 190.6 | 755.2 ± 167.6 | 788.8 ± 181.0 |
| Patients with right sided deficits(Participants) | Training in the Blind Field | Training in the Intact Field | Total |
|---|---|---|---|
| Count of participants | 10 | 10 | 20 |
| Time since lesion(months) | Training in the Blind Field | Training in the Intact Field | Total |
|---|---|---|---|
| Median | 15.0 (5.7 to 47.3) | 15.5 (6.2 to 57.6) | 15.28 (6.1 to 47.3) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Mar 2018 to primary completion in Dec 2019, 20 months.
Results were first posted in Dec 2020, 1 year after primary completion.
Of 36 interventional studies with no phase under Hemianopsia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 95. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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