- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07606300
Effect of Fixation Training With Colored Light Targets on Traumatic Brain Injury-Associated Photophobia
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Andrew Hartwick, OD, PhD
- 전화번호: 16146888308
- 이메일: HARTWICK.4@osu.edu
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- 모병
- College of Optometry
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연락하다:
- Andrew Hartwick, OD, PhD
- 전화번호: 614-688-8308
- 이메일: HARTWICK.4@osu.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pupil Responses
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Symptom Survey
기간: 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
기간: From baseline visit to the end of 3 months of fixation training with each light color
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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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2023H0291
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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