Trial Outcomes & Findings for Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™ (NCT NCT02675751)

Last Updated: 2025-02-04

Results Overview

At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.

Recruitment status

COMPLETED

Study phase

Target enrollment

167 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-04

235 subjects were consented in the study, of which all 167 subjects have both eyes treated for a total of 334 treated eyes.

Unit of analysis: Eyes

Participant milestones
Measure	PRK Correction With iDesign System and STAR S4 IR Laser Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
Overall Study STARTED	167 334
Overall Study COMPLETED	151 302
Overall Study NOT COMPLETED	16 32

Reasons for withdrawal
Measure	PRK Correction With iDesign System and STAR S4 IR Laser Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
Overall Study Lost to Follow-up	16

Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™

Baseline characteristics by cohort
Measure	PRK Correction With iDesign System and STAR S4 IR Laser n=334 Eyes Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
Age, Continuous	26.6 Years STANDARD_DEVIATION 5.41 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	20 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 6 months

Population: Of the 334 eyes (167 subjects) treated in the study, 324 eyes (162 subjects) were available at 6 months for analysis.

At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.

Outcome measures
Measure	PRK Correction With iDesign System and STAR S4 IR Laser n=324 Eyes Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better	324 Eyes

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	PRK Correction With iDesign System and STAR S4 IR Laser n=167 participants at risk Surgeons performed wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
Eye disorders Retinal Detachment	0.60% 1/167 • Number of events 1 • 12 months
Eye disorders Anterior Uveitis	0.60% 1/167 • Number of events 1 • 12 months
Eye disorders Corneal Abrasions	1.2% 2/167 • Number of events 2 • 12 months
Eye disorders Corneal Infiltrate	1.2% 2/167 • Number of events 2 • 12 months
Eye disorders Corneal Haze	1.2% 2/167 • Number of events 3 • 12 months
Eye disorders Corneal Erosion	1.2% 2/167 • Number of events 2 • 12 months

Adverse event data not reported

Johnson & Johnson Surgical Vision

Phone: +1 408-273-4081

Principal investigator is a sponsor employee The sponsor must review results communications prior to public release and can embargo communications regarding trial results at any time.
Publication restrictions are in place

Restriction type: OTHER