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).
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Pete Kollbaum, PhD
- 電話番号：812-555-5500
- メール：kollbaum@iu.edu
研究場所
-
-
Indiana
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Bloomington、Indiana、アメリカ、47405
- 募集
- Clinical Optics Research Lab
-
コンタクト：
- Pete Kollbaum, PhD
- メール：kollbaum@iu.edu
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.)
|
|
アクティブコンパレータ：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.)
|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ghosting Quantification
時間枠：Day 1
|
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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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