Trial Outcomes & Findings for Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers (NCT NCT05748275)

Results Overview

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

1 month postoperatively

Results posted on

2024-09-19

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Argos, Then IOLMaster 700 Biometry measurements first with the Argos device followed by the IOLMaster 700 device.	IOLMaster 700, Then Argos Biometry measurements first with the IOLMaster 700 device followed by the Argos device.
Overall Study STARTED	40 40	40 40
Overall Study COMPLETED	40 40	40 40
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=80 Participants All subjects
Age, Continuous	72.2 years STANDARD_DEVIATION 6.9 • n=80 Participants
Sex: Female, Male Female	50 Participants n=80 Participants
Sex: Female, Male Male	30 Participants n=80 Participants

PRIMARY outcome

Timeframe: 1 month postoperatively

Outcome measures

Outcome measures
Measure	Argos n=80 Participants Biometry measurements with the Argos device.	IOLMaster 700 n=80 Participants Biometry measurements with the IOLMaster 700 device.
Mean Absolute Prediction Error (D)	0.21 diopters Standard Deviation 0.25	0.25 diopters Standard Deviation 0.24

SECONDARY outcome

Timeframe: 1 month postoperatively

Outcome measures

Outcome measures
Measure	Argos n=80 Eyes Biometry measurements with the Argos device.	IOLMaster 700 n=80 Eyes Biometry measurements with the IOLMaster 700 device.
Percentage of Eyes With Absolute Prediction Error 0.5 D or Less	91 percent	88 percent

SECONDARY outcome

Timeframe: 1 month postoperatively

Outcome measures

Outcome measures
Measure	Argos n=80 Participants Biometry measurements with the Argos device.	IOLMaster 700 n=80 Participants Biometry measurements with the IOLMaster 700 device.
Median Absolute Prediction Error (D)	0.14 diopters Interval 0.06 to 0.25	0.19 diopters Interval 0.09 to 0.29

Adverse Events

Argos

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IOLMaster 700

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 Sam Multack

Multack Eye Care

Phone: 815-889-3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place