Trial Outcomes & Findings for Assessment of Measurement Variability Across Automated Biometry Devices (NCT NCT06045325)

Results Overview

The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II.

Recruitment status

COMPLETED

Target enrollment

204 participants

Primary outcome timeframe

Day of visit

Results posted on

2025-05-13

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Myopic -1.00D Myopic patients with a diopter of at least -1.00 Orbscan II: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 700: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 500: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Atlas 9000: Diagnostic assessment to measure white-to-white. Lenstar 900: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Pentacam: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. iTrace: Diagnostic assessment to measure white-to-white and corneal thickness. Argos: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Manual caliper measurement: Manual diagnostic assessment to measure white-to-white.
Overall Study STARTED	204 408
Overall Study COMPLETED	204 408
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Measurement Variability Across Automated Biometry Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Myopic -1.00D n=408 eyes Myopic patients with a diopter of at least -1.00. All patients will receive scans with each device. Orbscan II: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 700: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. IOL Master 500: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Atlas 9000: Diagnostic assessment to measure white-to-white. Lenstar 900: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Pentacam: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. iTrace: Diagnostic assessment to measure white-to-white and corneal thickness. Argos: Diagnostic assessment to measure anterior chamber depth, white-to-white, and corneal thickness. Manual caliper measurement: Manual diagnostic assessment to measure white-to-white.
Age, Categorical <=18 years	0 Participants n=204 Participants
Age, Categorical Between 18 and 65 years	204 Participants n=204 Participants
Age, Categorical >=65 years	0 Participants n=204 Participants
Sex/Gender, Customized Not disclosed	204 Participants n=204 Participants

PRIMARY outcome

Timeframe: Day of visit

The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II.

Outcome measures

Outcome measures
Measure	Argos n=408 eyes Argos biometer	Atlas 9000 n=408 eyes Atlas 9000 biometer	Manual Caliper n=408 eyes Manual Caliper	IOLMaster 500 n=408 eyes IOLMaster 500 biometer	IOLMaster 700 n=408 eyes IOLMaster 700 biometer	iTrace n=408 eyes iTrace device	Lenstar LS900 n=408 eyes Lenstar LS900 biometer	Pentacam AXL Wave n=322 eyes Pentacam AXL Wave device	Pentacam HR n=408 eyes Pentacam HR device
The Correlation of White-to-white Measurements Between Biometric Devices.	0.89 Pearson correlation r Interval 0.87 to 0.91	0.65 Pearson correlation r Interval 0.59 to 0.71	0.53 Pearson correlation r Interval 0.46 to 0.6	0.60 Pearson correlation r Interval 0.54 to 0.66	0.82 Pearson correlation r Interval 0.78 to 0.85	0.78 Pearson correlation r Interval 0.74 to 0.82	0.87 Pearson correlation r Interval 0.84 to 0.89	0.84 Pearson correlation r Interval 0.81 to 0.87	0.84 Pearson correlation r Interval 0.81 to 0.87

PRIMARY outcome

Timeframe: Day of visit

The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II.

Outcome measures

Outcome measures
Measure	Argos n=408 eyes Argos biometer	Atlas 9000 n=408 eyes Atlas 9000 biometer	Manual Caliper n=408 eyes Manual Caliper	IOLMaster 500 n=408 eyes IOLMaster 500 biometer	IOLMaster 700 n=322 eyes IOLMaster 700 biometer	iTrace n=408 eyes iTrace device	Lenstar LS900 Lenstar LS900 biometer	Pentacam AXL Wave Pentacam AXL Wave device	Pentacam HR Pentacam HR device
The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.	0.91 Pearson correlation r Interval 0.9 to 0.93	0.39 Pearson correlation r Interval 0.31 to 0.47	0.33 Pearson correlation r Interval 0.24 to 0.41	0.41 Pearson correlation r Interval 0.33 to 0.49	0.95 Pearson correlation r Interval 0.94 to 0.96	0.96 Pearson correlation r Interval 0.96 to 0.97	—	—	—

PRIMARY outcome

Timeframe: Day of visit

Population: Note that the iTrace, IOLMaster 500, Atlas 9000, and manual caliper did not measure central corneal thickness, so no central corneal thickness data were collected from these devices.

The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II.

Outcome measures

Outcome measures
Measure	Argos n=408 eyes Argos biometer	Atlas 9000 n=408 eyes Atlas 9000 biometer	Manual Caliper n=408 eyes Manual Caliper	IOLMaster 500 n=322 eyes IOLMaster 500 biometer	IOLMaster 700 n=408 eyes IOLMaster 700 biometer	iTrace iTrace device	Lenstar LS900 Lenstar LS900 biometer	Pentacam AXL Wave Pentacam AXL Wave device	Pentacam HR Pentacam HR device
The Correlation of Corneal Thickness Measurements Between Biometric Devices.	0.82 Pearson correlation r Interval 0.78 to 0.85	0.80 Pearson correlation r Interval 0.76 to 0.83	0.68 Pearson correlation r Interval 0.63 to 0.73	0.68 Pearson correlation r Interval 0.62 to 0.73	0.73 Pearson correlation r Interval 0.68 to 0.77	—	—	—	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tetiana Huff

Berkeley Eye Center

Phone: 713-620-7640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place