Impact of Patient Educational Level on Performance and Reliability in Humphrey Visual Field Testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Reliability and accuracy of Humphrey Visual Field (HVF) test performance based on the participant’s educational level.
研究概览
简要总结
Title: Impact of Patient Educational Level on Performance and Reliability in Humphrey Visual Field Testing
Background: Humphrey Visual Field (HVF) testing is a crucial diagnostic tool for detecting and monitoring glaucoma and other visual field defects. However, patient-related factors such as cognitive ability, attention span, and educational level may influence test performance and reliability. This study aims to evaluate whether a patient’s educational level affects their ability to perform HVF testing accurately and reliably.
Study Design: A cross-sectional observational study conducted at AIIMS, New Delhi.
Objectives:
- Primary Objective: To assess the impact of educational level on reliability indices (false positives, false negatives, fixation losses) and mean deviation (MD), pattern standard deviation (PSD), and testing duration in HVF testing.
- Secondary Objectives: To evaluate the role of cognitive and attention abilities (using the Trail Making Test A & B) and visual acuity (LogMAR conversion) in HVF test performance.
Methodology:
- Participants: Adults undergoing HVF testing, categorized based on their highest completed educational level.
- Assessments: Standard Humphrey 24-2 test, cognitive and attention assessment (TMT-A & B), and visual acuity measurement.
- Data Analysis: Comparison of HVF reliability indices across educational groups, correlation analysis with cognitive scores and visual acuity.
Expected Outcome: Identifying the role of education and cognitive function in HVF testing can help refine patient instructions and testing protocols, potentially reducing misdiagnoses due to poor test reliability.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: Adults aged 18 years and above.
- •Clinical Indication: Patients undergoing Humphrey Visual Field (HVF) 24-2 test as part of routine eye care or clinical evaluation for the first time.
- •Vision Status: Patients with a best-corrected visual acuity (BCVA) of 6/18 (0.48 logMAR) or better in the tested eye.
- •Educational Background: Patients with varied levels of education, ranging from no formal education to higher education (postgraduate level).
- •Cognitive and Physical Ability: Patients must be mentally and physically capable of understanding and following HVF test instructions.
- •Informed Consent: Patients willing to provide written informed consent to participate in the study.
排除标准
- •Severe Visual Impairment: Best-corrected visual acuity (BCVA) worse than 6/18 (0.48 logMAR) in the tested eye.
- •Media Opacities: Presence of significant cataract, corneal opacity, or vitreous haze that may interfere with visual field testing.
- •Neurological Disorders: History of stroke, dementia, or other neurocognitive impairments affecting the ability to perform the test reliably.
- •Hearing or Communication Impairment: Patients with severe hearing loss or language barriers that prevent understanding of test instructions.
- •Unstable Fixation: Patients with nystagmus or other ocular motor disorders leading to poor fixation control.
- •Previous Visual Field Testing Experience: Patients who have undergone HVF testing ever before (to minimize learning effects).
- •Ocular Conditions Affecting Visual Field: Advanced glaucoma, retinal diseases (e.g., severe diabetic retinopathy, retinal dystrophies), or optic nerve pathologies that could confound test performance.
- •Medication Use: Patients on CNS-active medications (such as sedatives, antidepressants) that could affect concentration and response time.
- •Refusal to Participate: Patients unwilling to provide informed consent.
结局指标
主要结局
Reliability and accuracy of Humphrey Visual Field (HVF) test performance based on the participant’s educational level.
时间窗: 1. Baseline (prior to HVF test) | 2. During the HVF test (real-time assessment) | 3. Immediately after the HVF test (post-test evaluation)
o Measured using false positives, false negatives, fixation losses, and mean deviation (MD) values.
时间窗: 1. Baseline (prior to HVF test) | 2. During the HVF test (real-time assessment) | 3. Immediately after the HVF test (post-test evaluation)
o Comparison across different educational levels.
时间窗: 1. Baseline (prior to HVF test) | 2. During the HVF test (real-time assessment) | 3. Immediately after the HVF test (post-test evaluation)
次要结局
- 1. Impact of Cognitive & Attention Abilities on HVF Performance(o Assessed using the Trail Making Test (TMT-A & B) & its correlation with HVF test reliability indices.)
研究者
Sanjay Kumar Mishra
AIIMS, New Delhi