Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
調査の概要
詳細な説明
A growing number of clinicians are regularly using fixation training, in which patients undergo daily sessions fixating on colored light targets on light boxes, to treat symptoms including photophobia associated with traumatic brain injury (TBI). While fixation training using various colored light targets is reported, blue light targets specifically appear to be used in this patient population more often than other light target colors. The College of Syntonic Optometry (www.csovision.org) estimates that there are roughly 500 practicing optometrists that utilize fixation training in the USA alone. However, evidence supporting this approach is primarily anecdotal, and there are no controlled, masked clinical trials published that evaluate the efficacy of this therapy against a control group.
Therefore, the goal of this study is to assess whether daily 20 min fixation training sessions using a blue light target alleviates symptoms of light sensitivity and alters pupil response more than daily 20 min fixation training sessions using red light targets in a masked cross-over clinical trial involving participants with chronic TBI-associated photophobia. In addition, we will determine if any improvement in symptomology correlates to any changes in pupil responses to red, blue and white light pulses and potential changes in other standard clinical measures of visual function. In short, this study will compare the effect of fixation training using a blue light target to the effect of fixation training using a red light target in participants with chronic TBI-associated photophobia.
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:Andrew Hartwick, OD, PhD
- 電話番号:16146888308
- メール:HARTWICK.4@osu.edu
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43210
- 募集
- College of Optometry
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コンタクト:
- Andrew Hartwick, OD, PhD
- 電話番号:614-688-8308
- メール:HARTWICK.4@osu.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 18 to 80 years old and subjects able to consent for themselves
- Completion of first session in entirety (participants who cannot complete the entire first visit will be considered as a screen fail)
- Best-corrected visual acuity of at least 20/32 in both the right and left eyes, and 20/25 using both eyes
- Prior head injury with current photophobia - A mild or moderate TBI occurring at least 3 months prior to visit, verified by a score of 2, 3 or 4 on OSU-TBI survey, and participant reports having experienced greater light sensitivity since their head injury
Exclusion Criteria:
- Pregnancy or suspected pregnancy - based on self-report
- Previous history of neurodegenerative disease (e.g. Alzheimer's, Parkinson's, multiple sclerosis, myasthenia gravis, seizures)
- History of pathology of the retina and optic nerve (includes retinal tears, diabetic retinopathy, glaucoma, macular degeneration, optic nerve atrophy)
- Currently on cholinergic medications, which affect pupil responses
- Prior participation in fixation training sessions within the past 2 years
- Experiencing a migraine during visit
- Prior history of severe TBI (score of 5 or 6 on OSU-TBI survey)
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:処理
- 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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Red light first, blue light second
Red light first, blue light second for the colored target used in the fixation training
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Red versus blue targets in light boxes used for fixation training
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実験的:Blue light first, red light second
Blue light first, red light second for the colored target used in the fixation training
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Red versus blue targets in light boxes used for fixation training
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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 |
|---|---|---|
|
Pupil Responses
時間枠:From baseline visit to the end of 3 months of fixation training with each light color
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Pupil responses to red, blue and white light stimuli
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From baseline visit to the end of 3 months of fixation training with each light color
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Symptom Survey
時間枠:From baseline visit to the end of 3 months of fixation training with each light color
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Symptom survey
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From baseline visit to the end of 3 months of fixation training with each light color
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|
Vergence facility
時間枠:From baseline visit to the end of 3 months of fixation training with each light color
|
Measurement of vergence range (how well eyes work together) with loose prisms
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From baseline visit to the end of 3 months of fixation training with each light color
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Stereopsis
時間枠:From baseline visit to the end of 3 months of fixation training with each light color
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Measurement of local stereopsis (depth perception) with Randot test
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From baseline visit to the end of 3 months of fixation training with each light color
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Phoria magnitude
時間枠:From baseline visit to the end of 3 months of fixation training with each light color
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Measure of phorias (how well eyes are aligned) using cover test and loose prisms
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From baseline visit to the end of 3 months of fixation training with each light color
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Near Point of Convergence
時間枠:From baseline visit to the end of 3 months of fixation training with each light color
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Measure of ability for eyes to converge (how well eyes turn in when reading up close)
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From baseline visit to the end of 3 months of fixation training with each light color
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協力者と研究者
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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