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Comparison between a novel device and conventional sight testing methods to determine spectacle prescription: Accuracy and speed of measurement

Comparison of the accuracy and duration of refractive error measurements determined using a novel, semi-automated measuring device versus conventional refraction techniques, in a normal optometric population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16974179
Enrollment
50
Registered
2016-05-30
Start date
2016-08-02
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive error Eye Diseases Refractive error

Interventions

Participants will have their refractive error measured as part of their standard eye examination (auto-refractor and subjective refinement using a phoropter and letter chart), during which the time ta

Sponsors

Topcon Eye Care Company
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Registered, returning customers attending the optometry practice for a routine, full NHS or private eye examination, during the trial period 2. Aged betwen 13 and 45 years 3. Visual acuity (VA) in each eye better than 0.1 logarithm of the minimum angle of resolution (6/7.5) as determined from their previous records or during the eye examination

Exclusion criteria

Exclusion criteria: 1. New customers attending the optometry practice for the first time 2. Patients attending for any other kind of optometric appointment other than a full eye examination 3. Those requiring significant adaptions to the standard subjective refraction process used in the eye examination, due to mental capacity/language. This includes the need to measure vision with picture or symbol charts rather than a letter chart 4. Individuals who do not exhibit normal binocular vision (ability for the two eyes to work together), including: 4.1. Subjects who report double vision as a symptom during the eye examination 4.2. Subjects who are found to have unstable binocular vision during the eye examination requiring the prescribing of exercises or prisms 4.3. Individuals with a history of lazy eye (amblyopia), suppression of vision in one eye and/or squint (turn in the eye) as recorded in their previous clinical records, or identified during the eye examination 5. Individuals with any ocular pathology or history of ocular surgery, including conditions known to affect the accuracy refraction measurements (media opacities) 6. Vulnerable subjects – will not be recruited on the basis that they would normally undergo a modified rather than the eye examination, adapted to meet their needs

Design outcomes

Primary

MeasureTime frame
1. Time taken to measure refractive error, including movement of participant between devices during the eye examination is measured using a stopwatch 2. Refractive outcome (sphere and cylinder) measured during the eye examination using conventional methods and with the prototype device (undertaken after the eye examination) 3. Number of times a participant must change seats is measured at the end of assessing each participant

Secondary

MeasureTime frame
1. Ease of use is rated by investigator using a questionnaire designed for the purpose of this study at the end of assessing each participant 2. Space taken up by prototype device versus conventional devices is assessed once at the start of the trial

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026