VisionApp - Ghosting
Assessment of the Accuracy and Repeatability of the VisionApp - Ghosting Measurement Protocol
Recent Android mobile device technology is available which allows user-measured refractive error and reading add power. This technology could be quite useful to the clinical and research community. The current study aims to evaluate the accuracy, repeatability, and reproducibility of one such technology by VisionApp, specifically with regard to ghosting vision.
VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc).
Přehled studie
Postavení
Podmínky
Detailní popis
Subjects will be enrolled at the Clinical Optics Research Lab at Indiana University.
At the study visit, demographic and health/ocular history may be collected by oral history and standard clinical testing including refraction (check of glasses prescription), auto-refraction or abbrerometry may be performed. Visual acuity and room lighting checks may also be measured using standard clinical techniques.
For the experimental portion of the study visit, participants will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales, while wearing different contact lenses. Participants will first be asked to wear commercially available single vision contact lenses to establish best corrected vision. A single vision lens will then remain in one eye, and participants will proceed with ghosting assessments using two different multifocal contact lenses worn in the other eye. Adult participants will perform the ghosting assessments while wearing 2 commercially available multifocal lenses, and children participants will perform the ghosting assessments while wearing a commercially available and investigational lens. Randomization will determine which lens is worn first.
If participants are unable to complete all testing in a single session, they may be permitted to return on a subsequent day.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Pete Kollbaum, PhD
- Telefonní číslo: 812-555-5500
- E-mail: kollbaum@iu.edu
Studijní místa
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Indiana
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Bloomington, Indiana, Spojené státy, 47405
- Nábor
- Clinical Optics Research Lab
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Kontakt:
- Pete Kollbaum, PhD
- E-mail: kollbaum@iu.edu
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- has a refractive error between Plano and -5.00 D of sphere and cylinder components combined.
- has refractive cylinder (e.g., astigmatism) of -0.75 D or less
- has had a self-reported oculo-visual exam in the last 2 years
- has best-corrected visual acuity of at least 20/20 in each eye
- is not amblyopic or does not have any diagnosed ocular disease
- is willing and able to follow instructions and maintain the appointment schedule
Exclusion Criteria:
- has any systemic disease affecting ocular health and visual acuity
- is currently using any systemic or topical medications that could affect ocular health and visual acuity
- is participating in another eye related research study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Adults: Lens 1, then Lens 2
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales.
This will be performed twice, while wearing two different soft multifocal contact lenses in one eye.
The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized.
After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
MyDay is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a MyDay contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
NaturalVue is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a NaturalVue contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc.)
|
|
Aktivní komparátor: Adults: Lens 2, then Lens 1
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales.
This will be performed twice, while wearing two different soft multifocal contact lenses in one eye.
The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized.
After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
MyDay is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a MyDay contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
NaturalVue is a commercially available multifocal soft contact lens for daily wear.
Adult participants will assess images for ghosting while wearing a NaturalVue contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc.)
|
|
Aktivní komparátor: Children: Lens 3, then Lens 4
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales.
This will be performed twice, while wearing two different soft multifocal contact lenses in one eye.
The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized.
After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc.)
MiSight 1 Day is a commercially available multifocal soft contact lens for daily wear.
Children participants will assess images for ghosting while wearing a MiSight 1 Day contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
An investigational multifocal soft contact lens for daily wear.
While the contact lens is made of an FDA approved material which is already marketed in the United States, it differs from commercially available lenses in that it has a slightly different optical design.
Children participants will assess images for ghosting while wearing this investigational contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
|
|
Aktivní komparátor: Children: Lens 4, then Lens 3
Subjects will be asked to look at letters and describe any shadows or distortions they see using slider bars or numerical rating scales.
This will be performed twice, while wearing two different soft multifocal contact lenses in one eye.
The order in which the participant wears each of the multifocal contact lenses for these tasks will be randomized.
After the assessment while wearing the first multifocal lens is completed, subjects will repeat the task while wearing the second multifocal lens.
|
Proclear 1 day is a commercially available single vision soft contact lens for single use (daily wear).
Participants will wear these contacts at the beginning of the study visit to establish best corrected vision.
Participants will then continue to wear this contact lens in one eye for the duration of the study visit.
VisionApp is an app which runs on a smartphone or other device which uses the distance between the user's face and the phone to determine refractive error, while the user looks at different targets (lines, letters, words, etc.)
MiSight 1 Day is a commercially available multifocal soft contact lens for daily wear.
Children participants will assess images for ghosting while wearing a MiSight 1 Day contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
An investigational multifocal soft contact lens for daily wear.
While the contact lens is made of an FDA approved material which is already marketed in the United States, it differs from commercially available lenses in that it has a slightly different optical design.
Children participants will assess images for ghosting while wearing this investigational contact lens in one eye.
Order of exposure to this lens will be determined via randomization.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Ghosting Quantification
Časové okno: Day 1
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Ghosting quantification (e.g. how "doubled" the image looks) will be compared against expected template images and those predicted. Subjects will provide a quality rating of ghosting on a scale between 0 - 100, with lower scores indicating more ghosting of the image and 100 representing an optically perfect image. The VisionApp will also model ghosting measurements for direction, separation, blur and strength into a predictive quality rating, which will be compared to the subject's subjective expected, or overall, quality rating. |
Day 1
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12501b
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produkt vyrobený a vyvážený z USA
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