Trial Outcomes & Findings for Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study (NCT NCT06085131)

Results Overview

Recruitment status

COMPLETED

Target enrollment

523 participants

Primary outcome timeframe

2 months postoperative

Results posted on

2026-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	Argos Biometer Preoperative biometry with the Argos device Argos: Argos Biometer
Overall Study STARTED	523
Overall Study COMPLETED	523
Overall Study NOT COMPLETED	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	Argos Biometer n=523 Participants Preoperative biometry with the Argos device Argos: Argos Biometer
Age, Continuous	71.6 years STANDARD_DEVIATION 7.23 • n=523 Participants
Sex: Female, Male Female	316 Participants n=523 Participants
Sex: Female, Male Male	207 Participants n=523 Participants

PRIMARY outcome

Timeframe: 2 months postoperative

Outcome measures

Outcome measures
Measure	Argos Biometer n=523 Eyes Preoperative biometry with the Argos device Argos: Argos Biometer	BUII Preoperative planning with the Argos biometer and BUII formula
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D.	489 Eyes	—

SECONDARY outcome

Timeframe: 2 months postoperative

Outcome measures

Outcome measures
Measure	Argos Biometer n=523 Eyes Preoperative biometry with the Argos device Argos: Argos Biometer	BUII Preoperative planning with the Argos biometer and BUII formula
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D. ≤ ±0.250D	352 Eyes	—
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D. ≤ ±0.750D	518 Eyes	—
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D. ≤ ±1.00D	523 Eyes	—

SECONDARY outcome

Timeframe: 2 months postoperative

Population: Overall absolute prediction error of two formulas were compared, the BTAL and BUII. The same eyes were used for both formulas. BTAL = Barrett true axial length; BUII = Barrett universal II

Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better.

Outcome measures

Outcome measures
Measure	Argos Biometer n=523 Eyes Preoperative biometry with the Argos device Argos: Argos Biometer	BUII n=523 Eyes Preoperative planning with the Argos biometer and BUII formula
Mean Absolute Prediction Error (in Diopters)	0.21 D Standard Deviation 0.16	0.22 D Standard Deviation 0.17

SECONDARY outcome

Timeframe: 2 months postoperative

Population: Absolute prediction error of two formulas were compared in the BTAL and BUII, in different length eyes. The same eyes were used in both formulas. BTAL = Barrett true axial length; BUII = Barrett universal II

The Mean Predictive Errors in Short AL\<22.5mm, Long AL \>24.5mm and Medium AL 22.6mm to 24.4mm eyes. Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better.

Outcome measures

Outcome measures
Measure	Argos Biometer n=523 Eyes Preoperative biometry with the Argos device Argos: Argos Biometer	BUII n=523 Eyes Preoperative planning with the Argos biometer and BUII formula
Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm Long Eyes	0.19 D Standard Deviation 0.15	0.20 D Standard Deviation 0.15
Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm Medium Eyes	0.21 D Standard Deviation 0.16	0.16 D Standard Deviation 0.17
Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm Short Eyes	0.19 D Standard Deviation 0.23	0.29 D Standard Deviation 0.22

Adverse Events

Argos Biometer

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

H. John Shammas

hammas Eye Medical Center

Phone: 3106389391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place