Trial Outcomes & Findings for Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract (NCT NCT03035292)

Last Updated: 2023-11-07

Results Overview

True positives: the number of eyes with cataract correctly identified True negatives: the number of eyes without cataract correctly identified False positives: the number of eyes without cataracts incorrectly identified as having cataract False negatives positives: the number of eyes with cataract incorrectly identified as not having cataract

Recruitment status

COMPLETED

Target enrollment

110 participants

Primary outcome timeframe

1 day

Results posted on

2023-11-07

Participant Flow

Diagnostic accuracy comparison trial: children from 1 month to 5 years of age (with no previous history of ophthalmic surgery) attending a specialist paediatric out-patient clinic were enrolled into the study over a 3 month period.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Children Recruited to Diagnostic Comparison Study Right eyes of children recruited to the study who underwent the following sequential examinations at the time of their clinic appointment: 1) red-reflex assessment by a medical student using direct ophthalmoscope 2) infrared-reflex assessment by the same medical student using the choroidal reflectance imaging device and 3) gold standard ophthalmic examination.
Overall Study STARTED	110 110
Overall Study COMPLETED	110 110
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Infrared Choroidal Reflectance Camera for the Detection of Childhood Cataract

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children Recruited to Diagnostic Comparison Study n=110 Eyes The data from right eyes of 110 children recruited to diagnostic accuracy comparison trial from clinic. These patients had initial red-reflex assessment (Intervention 1) and then infrared-reflex assessment (intervention 2) performed by a medical student prior to gold standard examination by a paediatric ophthalmologist
Age, Continuous	4 years STANDARD_DEVIATION 3.45 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race/Ethnicity, Customized ethnicity · white	89 Participants n=5 Participants
Race/Ethnicity, Customized ethnicity · black, asian, minority ethnic	21 Participants n=5 Participants
Evaluator assessment of reflex	110 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 110 children were eligible for the study, each had their right eye assessed by a medical student using 1) red-reflex assessment 2) Infrared-reflex assessment. Findings were compared to a gold standard examination by an ophthalmologist.

Outcome measures

Outcome measures
Measure	Eyes Tested in the Diagnostic Comparison Study n=110 Participants Eyes of children having red-reflex and infrared reflex tests
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Red-reflex test true positive	17 eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Red-reflex test true negative	54 eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Red-reflex test false positive	32 eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Red-reflex test false negative	7 eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Infrared-reflex test true positive	24 eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Infrared-reflex test true negative	86 eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Infrared-reflex test false positive	0 eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Infrared-reflex test false negative	0 eyes

PRIMARY outcome

Timeframe: 1 day

Population: 110 eyes (of 110 children) recruited to the study

Sensitivity (percentage of eyes with cataract correctly identified) and specificity (percentage of eyes without cataract correctly identified) of red-reflex and infrared-reflex testing in percentage terms with 95% Confidence Intervals. Sensitivity and specificity are recorded as a percentage, with 100% indicating best accuracy.

Outcome measures

Outcome measures
Measure	Eyes Tested in the Diagnostic Comparison Study n=110 Eyes Eyes of children having red-reflex and infrared reflex tests
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Sensitivity of red-reflex	71 percentage of eyes Interval 58.0 to 89.0
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Sensitivity of infrared-reflex	100 percentage of eyes Interval 83.0 to 100.0
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Specificity of red-reflex	63 percentage of eyes Interval 53.0 to 73.0
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Specificity of infrared-reflex	100 percentage of eyes Interval 95.0 to 100.0

SECONDARY outcome

Timeframe: 1 day

Population: of 110 eligible children, 89 (81%) were caucasian, 21(19%) were of Black, Asian or minority ethnicity (BAME)

True positives: the number of eyes with cataract correctly identified in caucasian children's eyes and in BAME children's eyes. True negatives: the number of eyes without cataract correctly identified in caucasian children's eyes and in BAME children's eyes. False positives: the number of eyes without cataract incorrectly identified as having cataract in caucasian children's eyes and in BAME children's eyes. False negatives: the number of eyes with cataract incorrectly identified as not having cataract in caucasian children's eyes and in BAME children's eyes.

Outcome measures

Outcome measures
Measure	Eyes Tested in the Diagnostic Comparison Study n=110 Eyes Eyes of children having red-reflex and infrared reflex tests
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex true positives in BAME children's eyes	2 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex true negatives in BAME children's eyes	5 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex false positives in BAME children's eyes	14 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex false negatives in BAME children's eyes	0 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex true positives in white children's eyes	15 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex true negatives in white children's eyes	49 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex false positives in white children's eyes	18 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Red-reflex false negatives in white children's eyes	7 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex true positives in BAME children's eyes	2 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex true negatives in BAME children's eyes	19 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex false positives in BAME children's eyes	0 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex false negatives in BAME childrens' eyes	0 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex true postives in white children's eyes	22 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex true negatives in white children's eyes	67 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex false positives in white children's eyes	0 Eyes
Results of Red-reflex and Infrared-reflex Tests Compared to Gold Standard Stratified by Ethnicity Infrared-reflex false negatives in white children's eyes	0 Eyes

SECONDARY outcome

Timeframe: 1 day

Population: 89 (81%) were the eyes of caucasian children, 21(19%) were the eyes of Black, Asian or minority ethnicity (BAME) children

Outcome measures

Outcome measures
Measure	Eyes Tested in the Diagnostic Comparison Study n=110 Eyes Eyes of children having red-reflex and infrared reflex tests
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity Sensitivity of red-reflex in caucasian eyes	69 percentage of eyes Interval 49.0 to 88.0
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity Sensitivity of red-reflex in BAME eyes	100 percentage of eyes Interval 20.0 to 100.0
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity Specificity of red-reflex in caucasian eyes	72 percentage of eyes Interval 61.0 to 82.0
Sensitivity and Specificity of Red-reflex and Infrared-reflex Testing Stratified by Ethnicity Specificity of red-reflex in BAME eyes	32 percentage of eyes Interval 11.0 to 53.0

Adverse Events

Children Recruited to Diagnostic Comparison Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Stephen Kelleher, Director of R&D

Cambridge University Hospitals NHS Trust

Phone: 01223 217418

Email: r&[email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place