Refractive ErrorNCT01365884
First-Sight Refractive Error Correction: Direct Comparison to Autorefraction Results in Children 7 to 18 Years of Age
An observational study of Refractive Error, run by University of Nebraska at 1 site in United States.
Trial summary
Proof of concept study to compare the best corrected visual acuity obtained via First-Sight lenses with the autorefraction in children. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Error
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2011to 12 Feb 2014
- Phase
- Observational
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Population with refractive error between -4.50 to +4.50 diopter spherical error and astigmatism up to -1.50 diopters.
Who may be able to join
- Subjects are between 7 to 18 years of age.
- Healthy subjects
- A refractive error of -4.50 to +4.50 diopter spherical error and astigmatism up to -1.50 diopters on manifest refraction and autorefraction as documented in their medical records.
- Best corrected visual acuity (BCVA) of 20/20 with cycloplegic refraction.
- No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.
Who cannot join
- Refractive error greater than -4.50 or +4.50 diopter, or astigmatism greater than -1.50 diopters.
- Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
- Best corrected visual acuity with spectacles of 20/25 or worse.
- Any previous surgical or laser procedures that may limit BCVA
- Narrow angles of the eyes
- Adults, 19 years or older
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Department of Ophthalmology
Omaha, Nebraska, 68198-5540
About this study
Official title: Proof of Concept Study for First-Sight Refractive Error Correction: Direct Comparison to Autorefraction Results in Children 7 to 18 Years of Age
Proof of concept study to compare the best corrected visual acuity obtained via First-Sight lenses with the autorefraction in children.
Read the detailed description
Uncorrected refractive error is a frequent cause of visual impairment in children most prevalent in rural or underserved areas in the global population. In 2006, the World Health Organization released global estimates on visual impairment. According to their findings, there are approximately 314 million people in the world whose vision is impaired. Of this population 90% of those individuals live in developing countries and 153 million cases are believed to be due to uncorrected refractive error. Children, ages five to 15 years, suffer from refractive errors (mostly myopia, hyperopia, and astigmatism) that can be improved to normal vision. It is estimated that by 2020, approximately one third of the world's population (2.5 billion) will be affected by myopia alone14. The prevalence of refractive error in school-aged children is significant especially the impact on a child's life in terms of education and development.
Studies in Western populations have collectively shown that myopia occurs <5% in children 8 years and younger. Sampling studies in other countries worldwide have shown that there is higher prevalence of myopia among Southeast Asia children and less among Australian children.1-11 Refractive error study in Eastern Nepal found 2.9% of children had vision of 20/40 or worse of which 56% of the 200 eyes tested was caused by refractive error due to myopia, hyperopia and astigmatism.12
The challenge is to determine the most effective and accessible method of detecting refractive error and dispensing spectacles for better vision. Children who have access to clinical setting typically receive prescriptive spectacles to correct refractive errors. However, in underserved areas where standard eye care may be absent, children are unable to receive the benefits of normal or near normal vision. The challenge is to determine the most effective and accessible method of detecting refractive error and dispensing spectacles for better vision
In the clinical setting, refractive error is corrected by prescribing spectacles or contact lenses on a daily basis. Typically the patient will first undergo autorefraction, in which a computer-controlled machine objectively calculates the refractive error present as a starting point for the subjective refraction test. This machine, however, is cumbersome and not easily transportable abroad. Typically the machine is held up to the patient's forehead and they are asked to look into the machine at a distant object. While they are looking at this object the machine calculates the refractive error.
First-Sight is a simplified way to correct refractive error. It is easily portable, making it accessible to remote areas of the world. Unlike the study cited above, First-Sight can be taken to remote areas where clinics are not available and patients are not able to afford to pay for the clinic visit. As it is a simplified technique, local health care workers may easily be able to learn how to use First-Sight and dispense spectacles to those in need. Lastly, sponsors of First-Sight will provide the refracting kit and dispense custom-made spectacles at no cost to health care workers and children respectively.
- Conditions
- Refractive Error
- Medical subject headings
- Refractive Errors
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare refracting methods
Will measure children's vision with First-Sight refracting kit and compare it to the two standard methods used in clinics.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study start5 Aug 2011
- Primary completion12 Feb 2014
- Study completion12 Feb 2014
Why it stopped: Low subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Feilmeier, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365884
- Sponsor's protocol ID
- 0201-11-FB
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2011
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study for First-Sight Refractive Error Correction: Direct Comparison to Autorefraction Results in Children 7 to 18 Years of Age
- ClinicalTrials.gov ID
- NCT01365884
- Acronym / sponsor ID
- 0201-11-FB
- Conditions
- Refractive Error
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low subject recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 5 Aug 2011 (actual)
- Primary completion
- 12 Feb 2014 (actual)
- Study completion
- 12 Feb 2014 (actual)
- First posted
- 3 Jun 2011 (estimated)
- 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.
Proof of concept study to compare the best corrected visual acuity obtained via First-Sight lenses with the autorefraction in children.
Detailed description
Uncorrected refractive error is a frequent cause of visual impairment in children most prevalent in rural or underserved areas in the global population. In 2006, the World Health Organization released global estimates on visual impairment. According to their findings, there are approximately 314 million people in the world whose vision is impaired. Of this population 90% of those individuals live in developing countries and 153 million cases are believed to be due to uncorrected refractive error. Children, ages five to 15 years, suffer from refractive errors (mostly myopia, hyperopia, and astigmatism) that can be improved to normal vision. It is estimated that by 2020, approximately one third of the world's population (2.5 billion) will be affected by myopia alone14. The prevalence of refractive error in school-aged children is significant especially the impact on a child's life in terms of education and development.
Studies in Western populations have collectively shown that myopia occurs <5% in children 8 years and younger. Sampling studies in other countries worldwide have shown that there is higher prevalence of myopia among Southeast Asia children and less among Australian children.1-11 Refractive error study in Eastern Nepal found 2.9% of children had vision of 20/40 or worse of which 56% of the 200 eyes tested was caused by refractive error due to myopia, hyperopia and astigmatism.12
The challenge is to determine the most effective and accessible method of detecting refractive error and dispensing spectacles for better vision. Children who have access to clinical setting typically receive prescriptive spectacles to correct refractive errors. However, in underserved areas where standard eye care may be absent, children are unable to receive the benefits of normal or near normal vision. The challenge is to determine the most effective and accessible method of detecting refractive error and dispensing spectacles for better vision
In the clinical setting, refractive error is corrected by prescribing spectacles or contact lenses on a daily basis. Typically the patient will first undergo autorefraction, in which a computer-controlled machine objectively calculates the refractive error present as a starting point for the subjective refraction test. This machine, however, is cumbersome and not easily transportable abroad. Typically the machine is held up to the patient's forehead and they are asked to look into the machine at a distant object. While they are looking at this object the machine calculates the refractive error.
First-Sight is a simplified way to correct refractive error. It is easily portable, making it accessible to remote areas of the world. Unlike the study cited above, First-Sight can be taken to remote areas where clinics are not available and patients are not able to afford to pay for the clinic visit. As it is a simplified technique, local health care workers may easily be able to learn how to use First-Sight and dispense spectacles to those in need. Lastly, sponsors of First-Sight will provide the refracting kit and dispense custom-made spectacles at no cost to health care workers and children respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Population with refractive error between -4.50 to +4.50 diopter spherical error and astigmatism up to -1.50 diopters.
Key inclusion criteria (5 listed)
- Subjects are between 7 to 18 years of age.
- Healthy subjects
- A refractive error of -4.50 to +4.50 diopter spherical error and astigmatism up to -1.50 diopters on manifest refraction and autorefraction as documented in their medical records.
- Best corrected visual acuity (BCVA) of 20/20 with cycloplegic refraction.
- No known ocular pathology from previous clinical exams that may limit best corrected visual acuity.
Key exclusion criteria (6 listed)
- Refractive error greater than -4.50 or +4.50 diopter, or astigmatism greater than -1.50 diopters.
- Known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit BCVA.
- Best corrected visual acuity with spectacles of 20/25 or worse.
- Any previous surgical or laser procedures that may limit BCVA
- Narrow angles of the eyes
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
Compare refracting methods
Time frame: 1 hour
Will measure children's vision with First-Sight refracting kit and compare it to the two standard methods used in clinics.
Results and safety
The study was stopped early (reason given: Low subject recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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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.
Michael Feilmeier, MD principal investigator
University of Nebraska
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 Refractive Error, run by University of Nebraska 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Aug 2023. 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?
The study was stopped early (reason given: Low subject recruitment). 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?
Compare refracting methods (time frame: 1 hour). 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 28 Aug 2023; AzTrials last refreshed its copy on 3 Nov 2026.