Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria
研究概览
简要总结
This study seeks to determine whether a smartphone application called CRADLE (ComputeR Assisted Detection of LEukocoria) has the potential to improve the detection of leukocoria. There will be no impact on participants' health outcome.
This study will be performed in two parts, each with a distinct cohort of patients.
Part 1 will assess the feasibility of various techniques/conditions for using CRADLE within patients known to have leukocoria.
Part 2 will estimate the sensitivity and specificity of CRADLE to detect leukocoria (using the techniques selected from information gathered in Part 1) as compared to an ophthalmoscope, within patients referred to the clinic for suspected leukocoria.
PRIMARY OBJECTIVES:
- To determine the most effective usage of a camera phone application (CRADLE) to maximize detection of leukocoria in patients with retinoblastoma, congenital cataracts, and glaucoma.
- To estimate the sensitivity and specificity of a camera phone application (CRADLE) in detecting leukocoria.
详细描述
This study will utilize three strata called Stratum I, Stratum II and Stratum III.
STRATUM I - Infants and children known to have leukocoria who have been diagnosed with retinoblastoma, cataracts or glaucoma or other eye conditions.
Participants enrolled on Stratum I of the study will have the CRADLE application used by the doctor during their appointment.
The participant will look straight forward while the doctor stands about 1-3 feet away holding the device that has the CRADLE application. He or she will slowly move the device up, down, middle, right, and left - both in a lit and dimmed room.
The participant will be videotaped and photographed during this appointment. The doctor will record the results as determined by CRADLE ("normal" or no leukocoria versus "abnormal" or positive for leukocoria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stratum I:
- •Patient has been diagnosed with congenital or infantile cataracts, congenital glaucoma, or retinoblastoma, and is scheduled for a visit with an ophthalmologist at St. Jude Children's Research Hospital or University of Tennessee Hamilton Eye Institute.
- •Patient with retinoblastoma is newly diagnosed, or has received < 2 cycles of chemoreductive therapy, and has not undergone enucleation.
- •Patient with cataracts or glaucoma has not received any prior therapy.
- •Inclusion Criteria - Stratum II:
- •Patient without prior diagnosis has been referred for ophthalmological evaluation, including leukocoria or other conditions.
- •Inclusion Criteria - Stratum III:
- •Patient with retinoblastoma undergoing ocular salvage treatment.
排除标准
- •Prior treatment for cataracts or glaucoma
- •Inability or unwillingness of research participant or legal guardian to consent.
研究组 & 干预措施
Stratum I: Initial Evaluation Group
Initially, a small group of patients diagnosed with congenital or infantile cataracts, congenital glaucoma or retinoblastoma and who meet the eligibility criteria will undergo testing with CRADLE on Day 1.
干预措施: CRADLE (Other)
Stratum II: Leukocoria Evaluation Group
A separate group of participants who are referred for evaluation of leukocoria or any other eye condition will undergo red reflex testing testing with CRADLE on Day 1.
干预措施: CRADLE (Other)
Stratum II: Leukocoria Evaluation Group
A separate group of participants who are referred for evaluation of leukocoria or any other eye condition will undergo red reflex testing testing with CRADLE on Day 1.
干预措施: Red reflex testing (Other)
Stratum III: Retinoblastoma Group
A separate group of participants with known retinoblastoma and who are undergoing ocular salvage treatments will be screened with red reflex testing using direct ophthalmoscopy on Day 1. They will also undergo testing with the CRADLE software application defined as the most effect in Stratum I on Day 1 then for three additional consecutive visits which typically occur every 3 to 4 weeks.
干预措施: CRADLE (Other)
Stratum III: Retinoblastoma Group
A separate group of participants with known retinoblastoma and who are undergoing ocular salvage treatments will be screened with red reflex testing using direct ophthalmoscopy on Day 1. They will also undergo testing with the CRADLE software application defined as the most effect in Stratum I on Day 1 then for three additional consecutive visits which typically occur every 3 to 4 weeks.
干预措施: Red reflex testing (Other)
结局指标
主要结局
Sensitivity of CRADLE versus ophthalmoscope to detect leukocoria
时间窗: Up to Day 4
The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of true positive. An ideal test for sensitivity has no false positives.
Specificity of CRADLE versus ophthalmoscope to detect leukocoria
时间窗: Up to Day 4
The test results obtained by CRADLE will be compared to those obtained by ophthalmoscopic examination to determine the effectiveness of detection of leukocoria by CRADLE. The results will be reported as number of false negatives (specificity). An ideal test for sensitivity has no false negatives.
Rate of detection of leukocoria using CRADLE
时间窗: Day 1
This outcome will assess the feasibility of various techniques and conditions for using CRADLE in participants with retinoblastoma, congenital cataracts, and glaucoma. The most effective usage of CRADLE to maximize detection of leukocoria will be determined by review of all images, and the most effective and efficient technique will be selected based on the findings and the clarity of the images. This technique will be used for completion of the subsequent objectives using a new cohort of participants.
次要结局
未报告次要终点