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Refractive ErrorNCT01342393

Proof of Concept Study for First-Sight Refractive Error Correction: Direct Comparison to Manifest Refraction and Autorefraction Results

An observational study of Refractive Error, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Proof of concept study is to compare the best corrected visual acuity obtained via First-Sight lenses with the clinical "gold standard" of manifest refraction and autorefraction. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Refractive Error
How many people
41 participants
Where
1 siteUnited States
Study dates
Apr 2011to Aug 2011
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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older 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 must be 19 years of age and older.
  • 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 the patient's medical records.
  • Best corrected visual acuity (BCVA) of 20/20 with manifest 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
  • 18 years of age and younger

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska Medical Center, Department of Ophthalmology

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Proof of Concept Study for First-Sight Refractive Error Correction:Direct Comparison to Manifest Refraction and Autorefraction Results

Proof of concept study is to compare the best corrected visual acuity obtained via First-Sight lenses with the clinical "gold standard" of manifest refraction and autorefraction.

Read the detailed description

Uncorrected refractive error is a frequent cause of visual impairment 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. The impact of uncorrected refractive error is great, including, but not limited to, loss of employment opportunities, inability to care for family, and inability to receive an education. 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 is used to objectively calculate 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. Next, the patient undergoes manifest refraction, a subjective refractive test that requires the use of trial lenses and patient responses to improve the results calculated by autorefraction, resulting in the best corrected visual acuity for that patient and a prescription for the patient to receive spectacles tailored to their need.

As a testimony to how prevalent uncorrected refractive error is in the developing world, refractive error in Nigerian adults and the prevalence of spectacle use was studied. In an article titled Refractive errors in Nigerian adults: prevalence, types and spectacle coverage, researchers looked at types of refractive errors and the ability of off the shelf spectacles to meet the corrective need in the 13,599 Nigerian adults. Patients underwent autorefraction and a detailed clinical exam and it was discovered that uncorrected refractive errors were responsible for 77.9% of visual impairment at the 20/40 to 20/60 level, and 57.1% at the 20/60 to 20/200 level. It also found that spectacles could improve the vision of 1,279 adults in the 20/40 range and 882 participants at the 20/60 level. However, only 3-4% of those individuals wore spectacles.

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 brought 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, the sponsor of First-Sight will provide the refracting kits and custom-made spectacles at no cost to the health care workers and patients.

Medical subject headings
Refractive Errors

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01342393
Sponsor's protocol ID
131-11
Status last verified
Jan 2012
First submitted
25 Apr 2011
Last updated
11 Jan 2012
Results posted
No
Data monitoring committee
No

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 4 inclusion and 5 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 11 Jan 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

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 11 Jan 2012.

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