Trial Outcomes & Findings for Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors (NCT NCT01675479)

Last Updated: 2021-12-15

Results Overview

Hypothesis: \<5% of eyes will have a loss of \> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters

Recruitment status

COMPLETED

Study phase

Target enrollment

167 participants

Primary outcome timeframe

12 Months

Results posted on

2021-12-15

Participant Flow

167 subjects were consented in the study, of which 69 subjects had one or both eyes treated for a total of 135 treated eyes.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Wavefront-Guided LASIK LASIK correction of hyperopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Overall Study STARTED	69 135
Overall Study COMPLETED	58 112
Overall Study NOT COMPLETED	11 23

Reasons for withdrawal

Reasons for withdrawal
Measure	Wavefront-Guided LASIK LASIK correction of hyperopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Overall Study Lost to Follow-up	11

Baseline Characteristics

Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wavefront-Guided LASIK n=69 Participants LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
Age, Continuous	42.7 years STANDARD_DEVIATION 11.8 • n=93 Participants
Sex: Female, Male Female	35 Participants n=93 Participants
Sex: Female, Male Male	34 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	58 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants
Region of Enrollment United States	69 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 Months

Hypothesis: \<5% of eyes will have a loss of \> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters

Outcome measures

Outcome measures
Measure	Wavefront-Guided LASIK n=131 eyes LASIK : Surgeons performed wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)	2 eyes

SECONDARY outcome

Timeframe: 12 Months

Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Outcome measures

Outcome measures
Measure	Wavefront-Guided LASIK n=131 eyes LASIK : Surgeons performed wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better	123 eyes

Adverse Events

Wavefront-Guided LASIK

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Wavefront-Guided LASIK n=69 participants at risk LASIK : Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System for correction of hyperopic refractive errors
Eye disorders Epithelial ingrowth requiring non refractive intervention	1.4% 1/69 • 24 months
Eye disorders Decrease in BSCVA	1.4% 1/69 • 24 months
Eye disorders Cataract	1.4% 1/69 • 24 months
Eye disorders Severe glare	1.4% 1/69 • 24 months

Other adverse events

Adverse event data not reported

Additional Information

Head of Clinical Science

Abbott Medical Optics

Phone: 714-247-8613

Email: [email protected]

Results disclosure agreements

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