Accommodative InsufficiencyADNCT01329848
Accommodation Disorders
An observational study of Accommodative Insufficiency and Ill-sustained Accommodation, run by Western University of Health Sciences at 1 site in United States.
Trial summary
This project will develop clinically useful, objective measurements of accommodative insufficiency and fatigue using continuous autorefraction recordings. The development of these procedures will help vision care professionals diagnose and treat accommodative anomalies. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Accommodative Insufficiency, Ill-sustained Accommodation
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Graduate students from Western University of Health Sciences
Who may be able to join
- older adolescent and young adult
- skilled readers who attend school
- are skilled readers
- have heavy reading demands
Who cannot join
- Age > 30.
- Abnormal vergence system.
- Dry-eye.
- Uncorrected visual defects or significant ocular pathology.
- Learning disability or low IQ
- Medical conditions that might cause uncomfortable visual symptoms (e.g., migraine headaches, epilepsy, head trauma); sensory defects (e.g., deafness), or neurological conditions (e.g., stuttering) that could impair reading development or oral reading fluency.
- Somatosensory amplification.
- Systemic illness or medication associated with accommodative dysfunction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
Official title: Using Accommodative Lag to Diagnose Accommodation Disorders
This project will develop clinically useful, objective measurements of accommodative insufficiency and fatigue using continuous autorefraction recordings. The development of these procedures will help vision care professionals diagnose and treat accommodative anomalies.
Read the detailed description
This project studies accommodative function, the ability to focus while doing near work. Visual discomfort symptoms, such as headaches, sore eyes, and blurred vision are commonly associated with prolonged reading or other near work. Researchers have long suspected accommodative dysfunction was involved but most clinical studies have failed to establish a relationship between weak accommodation and symptoms or reading impairments. Recent research, however, has found that clinical measure overestimate accommodative function and encourage the use of objective, autorefraction methods to measure and study accommodative weakness. This project will accomplish three goals. First, using autorefraction objective reliable procedures will be developed for measuring accommodative lag, the difference between the target location and where the eye is focused. Second, experiments will measure in real-time the impact of accommodative lag on reading fluency and visual discomfort systems. Third, studies will explore the role of the slow adaptive component in accommodative weakness. This work will lead to better methods for diagnosing and treating accommodative disorders.
- Keywords
- Accommodation, Reading, Autorefraction
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 |
|---|---|---|
| discomfort symptoms | level of discomfort symptoms while performing near work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodation Lag 5D
Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.
Measured: 3 week period
Secondary outcomes (1)
Conlon Symptom Survey
Measures visual discomfort symptoms while doing near work. 23 item survey using a 4-point rating scale (never, occasionally, often, almost always). Total raw score reported on a range from 0 to 69 with higher scores indicating more frequent symptoms.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Accommodative InsufficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Southern California College of Optometry at Marshall B. Ketchum University
- Responsible party
- Principal investigator, Christopher Chase, Western University of Health Sciences
- Investigators
- Chris Chase, PhD, Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329848
- Sponsor's protocol ID
- 1R15EY021021
- Acronym
- AD
- Status last verified
- Dec 2014
- First submitted
- 4 Apr 2011
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Accommodative Lag to Diagnose Accommodation Disorders
- ClinicalTrials.gov ID
- NCT01329848
- Acronym / sponsor ID
- AD / 1R15EY021021
- Keywords
- Accommodation, Reading, Autorefraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- Southern California College of Optometry at Marshall B. Ketchum University
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Posted 5 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will develop clinically useful, objective measurements of accommodative insufficiency and fatigue using continuous autorefraction recordings. The development of these procedures will help vision care professionals diagnose and treat accommodative anomalies.
Detailed description
This project studies accommodative function, the ability to focus while doing near work. Visual discomfort symptoms, such as headaches, sore eyes, and blurred vision are commonly associated with prolonged reading or other near work. Researchers have long suspected accommodative dysfunction was involved but most clinical studies have failed to establish a relationship between weak accommodation and symptoms or reading impairments. Recent research, however, has found that clinical measure overestimate accommodative function and encourage the use of objective, autorefraction methods to measure and study accommodative weakness. This project will accomplish three goals. First, using autorefraction objective reliable procedures will be developed for measuring accommodative lag, the difference between the target location and where the eye is focused. Second, experiments will measure in real-time the impact of accommodative lag on reading fluency and visual discomfort systems. Third, studies will explore the role of the slow adaptive component in accommodative weakness. This work will lead to better methods for diagnosing and treating accommodative disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| discomfort symptoms | – | –level of discomfort symptoms while performing near work |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Graduate students from Western University of Health Sciences
Key inclusion criteria (4 listed)
- older adolescent and young adult
- skilled readers who attend school
- are skilled readers
- have heavy reading demands
Key exclusion criteria (8 listed)
- Age > 30.
- Abnormal vergence system.
- Dry-eye.
- Uncorrected visual defects or significant ocular pathology.
- Learning disability or low IQ
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
Accommodation Lag 5D
Time frame: 3 week period
Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.
1 secondary outcome
Conlon Symptom Survey
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Accommodative Insufficiency
Not yet recruitingPhase 2
Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI
Convergence Insufficiency
Active, not recruiting
Comparison of Plus Lens Addition Versus Vision Therapy for Management of Accommodative Infacility
Accommodative Insufficiency
Recruiting
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
Convergence Insufficiency
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.
Chris Chase, PhD principal investigator
Western University of Health Sciences
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 Accommodative Insufficiency and Ill-sustained Accommodation, run by Western University of Health Sciences 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 4 inclusion and 8 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 Jan 2015. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accommodation Lag 5D (time frame: 3 week period). 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 Jan 2015.