NCT07704294尚未招募不适用
Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis
研究概览
简要总结
The goal of this observational study is to determine whether genetic information, together with clinical information, can be used to improve prediction of future multiple sclerosis (MS) diagnosis after a first-time episode of optic neuritis. The study will also investigate visual outcomes, quality of life, healthcare use, and the acceptability of using genetic information to predict future health outcomes in people with optic neuritis.
The main outcomes that we aim to assess are:
- Incident diagnosis of MS following a first episode of optic neuritis, including time to MS diagnosis.
- Visual outcomes following optic neuritis, including visual acuity, visual field, and colour vision.
- Clinical care received following optic neuritis, including specialist review, investigations/tests
- Health-related and vision-related quality of life.
- Health economic impacts and healthcare utilisation after experiencing optic neuritis
- Knowledge, attitudes, and practices/behaviours about using genetic information to predict future MS disease risk.
If consented, participants will:
- Allow researchers to review information from their medical records relating to their optic neuritis diagnosis, investigations, treatments, and outcomes.
- Be invited to provide a saliva sample for genetic analysis.
- Complete questionnaires about their lifestyle/risk factors, quality of life, and views on genetic risk prediction.
- Allow researchers to track long-term health outcomes using information from their NHS records
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16 years and above at time of consent
- •Previous episode of optic neuritis diagnosed at one of the participating sites
排除标准
- •Patients for whom data relating to the first episode of ON are not available in the medical record at a participating site
- •Children <16 years at the time of recruitment
结局指标
主要结局
Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis
时间窗: Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.
Occurrence of a diagnosis of multiple sclerosis following a first episode of optic neuritis.
次要结局
- Visual Acuity (LogMAR)(From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).)
- Visual Field Mean Deviation (dB)(From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).)
- Colour Vision (Number of Ishihara Plates Correctly Identified)(From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).)
- Number of Healthcare Consultations Following Optic Neuritis Diagnosis(12 months)
- Number of Investigations Performed Following Optic Neuritis Diagnosis(12 months)
- Time to Diagnostic Investigations Following Optic Neuritis Diagnosis (Days)(12 months)
- Time to Treatment Following Optic Neuritis Diagnosis (Days)(12 months)
- Number of Treatment Episodes Following Optic Neuritis Diagnosis(12 months)
- Health-Related Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire [EQ-5D-5L])(Measured at baseline recruitment and repeated 3-12 months later)
- Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25])(Baseline and repeated 3-12 months later)
- Optic Neuritis-Related Quality of Life (Semi-Structured Questionnaire)(Measured at baseline recruitment and repeated 3-12 months later)
- Fatigue (Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue 6a)(Baseline recruitment and repeated once 3-12 months later)
- Depression (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression 4a)(Baseline recruitment and repeated once 3-12 months later)
- Work Productivity Loss (Adapted iMTA Productivity Cost Questionnaire [iPCQ])(Baseline recruitment and repeated once 3-12 months later)
- Healthcare Resource Utilisation: Appointments, Emergency Department Attendances and Hospital Admissions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])(Baseline recruitment and repeated once 3-12 months later)
- Healthcare Resource Utilisation: Investigations and Treatment Interventions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])(Baseline recruitment and repeated once 3-12 months later)
- Informal Care Received (Hours)(Baseline recruitment and repeated once 3-12 months later)
- Out-of-Pocket Costs (Pounds Sterling)(Baseline recruitment and repeated once 3-12 months later)
- Knowledge, Attitudes and Practices/Behaviours Regarding Genetic Risk Prediction (KAP Questionnaire)(Baseline recruitment and repeated at 3-12 months later)
研究者
研究点 (3)
Loading locations...
相似试验
尚未招募
不适用
Correlation of Eye ultrasound Measurements with Neurological Outcome in Traumatic Brain Injury PatientsCTRI/2026/02/102850Department of Anaesthesiology,IMS,BHU100
招募中
不适用
Prospective Evaluation of the 2022 Optic Neuritis Criteria When Optic Neuritis Is SuspectedOptic NeuritisOptic NeuropathyNCT07623252First Affiliated Hospital of Guangxi Medical University500
招募中
不适用
Evaluation of visual recovery after Optic Neuritis(swelling of nerve of the eye) in a hospital in Coastal KarnatakaCTRI/2024/07/070115Kasturba Medical College Manipal57
尚未招募
不适用
Clinical Predictors of Visual Outcome in Patients Affected With Ocular Surface DiseasesNeurotrophic KeratopathyExposure KeratopathyLimbal Stem Cell Deficiency (LSCD)Cornea AbnormalityCornea DiseaseCornea InflamedNCT07694817IRCCS San Raffaele1,000
Unknown
不适用
创伤性视神经病变的队列研究ChiCTR2500104161自筹