Trial Outcomes & Findings for Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism (NCT NCT01675492)

Last Updated: 2025-02-04

Results Overview

\< 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

126 participants

Primary outcome timeframe

3 Months

Results posted on

2025-02-04

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Wave-front Guided LASIK Vision correction for a mixed astigmatism refraction
Overall Study STARTED	84 149
Overall Study COMPLETED	42 75
Overall Study NOT COMPLETED	42 74

Reasons for withdrawal

Reasons for withdrawal
Measure	Wave-front Guided LASIK Vision correction for a mixed astigmatism refraction
Overall Study study completed early - product approval	42

Baseline Characteristics

Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wave-front Guided LASIK n=149 eyes LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
Age, Continuous	36.3 years STANDARD_DEVIATION 10.36 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	5 Participants n=5 Participants
Race (NIH/OMB) White	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	84 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

\< 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	Wave-front Guided LASIK n=149 eyes LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)	149 eyes

SECONDARY outcome

Timeframe: 3 Months

85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Outcome measures

Outcome measures
Measure	Wave-front Guided LASIK n=149 eyes LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction
Uncorrected Visual Acuity (UCVA) of 20/40 or Better	149 eyes

Adverse Events

Wave-front Guided LASIK

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

Director, Clinical Operations

Abbott Medical Optics

Phone: 714-247-8628

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