Central Visual ImpairmentNCT03640130
Peripheral Reading
A study testing Gaze-contingent text enhancement in people with Central Visual Impairment, run by University of Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate reading performance in the visual periphery by simulating central vision loss using a computer-controlled gaze-contingent display with an eye tracker. Participants will read a page of text at a comfortable rate. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Visual Impairment
- What is being tested?
- Gaze-contingent text enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Mar 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal vision
- English language
Who cannot join
- Less than 20/20 vision in either eye
- Abnormalities which affect vision (amblyopia, keratoconus, etc.)
- Ortho-K lenses
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston, College of Optometry
Houston, Texas, 77204
About this study
Official title: Factors Limiting Peripheral Reading
The purpose of this study is to evaluate reading performance in the visual periphery by simulating central vision loss using a computer-controlled gaze-contingent display with an eye tracker. Participants will read a page of text at a comfortable rate. Several manipulations hypothesized to improve reading will be tested, such as an inverted-text "spotlight" of a single word that follows the participant's gaze.
Read the detailed description
Participants will view paragraphs of multiple sentences of text with their central vision blocked computationally with a "simulated scotoma." Participants will be free to move their eyes around the page of text at a comfortable rate. The three outcomes described elsewhere will be evaluated.
In different blocks, text will contain one or more of several dynamic assistive manipulations that are hypothesized to enhance reading: 1) inverting the text at a given position, with instructions for the participant to attend to that location, which simulates a "surrogate fovea" of a patient with central vision loss. 2) horizontally expanding text to alleviate within-word crowding. 3) highlighting the next word with a visible indicator to encourage proper eye movements.
- Conditions
- Central Visual Impairment
- Being tested
- Gaze-contingent text enhancement
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaze-contingent text enhancementBehavioural
In different testing blocks, the efficacy of the different enhancements will be evaluated, such as inverting the text in a gaze-contingent inverted "spotlight."
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Each participant will participate in several blocks (randomized order), to evaluate performance with and without behavioral gaze-contingent text enhancements. Receives: Behavioral: Gaze-contingent text enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speed
Average time/word it takes to read a paragraph of text.
Measured: From enrollment to completion of testing (<2 weeks)
Reading accuracy
Ability to correctly answer comprehension questions or orally read words
Measured: From enrollment to completion of testing (<2 weeks)
Efficiency of eye movement
Ability to move the eyes systematically from word to word
Measured: From enrollment to completion of testing (<2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Nov 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Visual ImpairmentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel R. Coates, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640130
- Sponsor's protocol ID
- STUDY00001096
- Status last verified
- Nov 2018
- First submitted
- 19 Aug 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To conform with open science directives, will likely post the de-identified behavioral data on a public server.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Limiting Peripheral Reading
- ClinicalTrials.gov ID
- NCT03640130
- Acronym / sponsor ID
- STUDY00001096
- Conditions
- Central Visual Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 21 Aug 2018 (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 reading performance in the visual periphery by simulating central vision loss using a computer-controlled gaze-contingent display with an eye tracker. Participants will read a page of text at a comfortable rate. Several manipulations hypothesized to improve reading will be tested, such as an inverted-text "spotlight" of a single word that follows the participant's gaze.
Detailed description
Participants will view paragraphs of multiple sentences of text with their central vision blocked computationally with a "simulated scotoma." Participants will be free to move their eyes around the page of text at a comfortable rate. The three outcomes described elsewhere will be evaluated.
In different blocks, text will contain one or more of several dynamic assistive manipulations that are hypothesized to enhance reading: 1) inverting the text at a given position, with instructions for the participant to attend to that location, which simulates a "surrogate fovea" of a patient with central vision loss. 2) horizontally expanding text to alleviate within-word crowding. 3) highlighting the next word with a visible indicator to encourage proper eye movements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Behavioral: Gaze-contingent text enhancementEach participant will participate in several blocks (randomized order), to evaluate performance with and without behavioral gaze-contingent text enhancements. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Normal vision
- English language
Key exclusion criteria (3 listed)
- Less than 20/20 vision in either eye
- Abnormalities which affect vision (amblyopia, keratoconus, etc.)
- Ortho-K lenses
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 |
|---|---|---|
| Gaze-contingent text enhancementIn different testing blocks, the efficacy of the different enhancements will be evaluated, such as inverting the text in a gaze-contingent inverted "spotlight." | Behavioural | Single Arm |
Primary outcome
Reading speed
Time frame: From enrollment to completion of testing (<2 weeks)
Average time/word it takes to read a paragraph of text.
Reading accuracy
Time frame: From enrollment to completion of testing (<2 weeks)
Ability to correctly answer comprehension questions or orally read words
Efficiency of eye movement
Time frame: From enrollment to completion of testing (<2 weeks)
Ability to move the eyes systematically from word to word
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Undecided. To conform with open science directives, will likely post the de-identified behavioral data on a public server.
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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.
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?
A study testing Gaze-contingent text enhancement in people with Central Visual Impairment, run by University of Houston at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. 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 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?
Results are not available in the source record.
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?
Reading speed (time frame: From enrollment to completion of testing (<2 weeks)). 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 14 Nov 2018; AzTrials last refreshed its copy on 27 Oct 2026.