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- Essai clinique NCT07606300
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Andrew Hartwick, OD, PhD
- Numéro de téléphone: 16146888308
- E-mail: HARTWICK.4@osu.edu
Lieux d'étude
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Ohio
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Columbus, Ohio, États-Unis, 43210
- Recrutement
- College of Optometry
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Contact:
- Andrew Hartwick, OD, PhD
- Numéro de téléphone: 614-688-8308
- E-mail: HARTWICK.4@osu.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: Blue light first, red light second
Blue light first, red light second for the colored target used in the fixation training
|
Red versus blue targets in light boxes used for fixation training
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pupil Responses
Délai: From baseline visit to the end of 3 months of fixation training with each light color
|
Pupil responses to red, blue and white light stimuli
|
From baseline visit to the end of 3 months of fixation training with each light color
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Symptom Survey
Délai: From baseline visit to the end of 3 months of fixation training with each light color
|
Symptom survey
|
From baseline visit to the end of 3 months of fixation training with each light color
|
|
Vergence facility
Délai: 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
|
From baseline visit to the end of 3 months of fixation training with each light color
|
|
Stereopsis
Délai: From baseline visit to the end of 3 months of fixation training with each light color
|
Measurement of local stereopsis (depth perception) with Randot test
|
From baseline visit to the end of 3 months of fixation training with each light color
|
|
Phoria magnitude
Délai: From baseline visit to the end of 3 months of fixation training with each light color
|
Measure of phorias (how well eyes are aligned) using cover test and loose prisms
|
From baseline visit to the end of 3 months of fixation training with each light color
|
|
Near Point of Convergence
Délai: From baseline visit to the end of 3 months of fixation training with each light color
|
Measure of ability for eyes to converge (how well eyes turn in when reading up close)
|
From baseline visit to the end of 3 months of fixation training with each light color
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Blessures et Blessures
- Maladies oculaires
- Troubles de la vision
- Troubles des sensations
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- Blessures à la tête, fermé
- Blessures non pénétrantes
- Lésions cérébrales
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Lésions cérébrales, traumatiques
- Commotion cérébrale
- Photophobie
Autres numéros d'identification d'étude
- 2023H0291
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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