- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07606300
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Andrew Hartwick, OD, PhD
- Telefonnummer: 16146888308
- E-post: HARTWICK.4@osu.edu
Studieorter
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43210
- Rekrytering
- College of Optometry
-
Kontakt:
- Andrew Hartwick, OD, PhD
- Telefonnummer: 614-688-8308
- E-post: HARTWICK.4@osu.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Red light first, blue light second
Red light first, blue light second for the colored target used in the fixation training
|
Red versus blue targets in light boxes used for fixation training
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pupil Responses
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Symptom Survey
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Sår och skador
- Ögonsjukdomar
- Synstörningar
- Sensationsstörningar
- Kraniocerebralt trauma
- Trauma, nervsystemet
- Huvudskador, stängt
- Sår, Icke-penetrerande
- Hjärnskador
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Hjärnskador, traumatiska
- Hjärnskakning
- Fotofobi
Andra studie-ID-nummer
- 2023H0291
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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