Trial Outcomes & Findings for Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors (NCT NCT01663363)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

170 participants

Primary outcome timeframe

6 Months

Results posted on

2025-02-04

Participant Flow

334 eyes were treated among 170 participants.

Participant milestones

Participant milestones
Measure	Wavefront-guided LASIK LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Overall Study STARTED	170
Overall Study COMPLETED	170
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wavefront-guided LASIK n=170 Participants LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	169 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants
Region of Enrollment United States	170 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Data from 334 eyes of 170 participants are included for the outcome measure "Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)".

Outcome measures

Outcome measures
Measure	Wavefront-guided LASIK n=334 eyes LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)	0 percentage of eyes Confidence intervals were not calculated because 0% of eyes lost more than 2 lines of BSCVA.

SECONDARY outcome

Timeframe: 6 Months

Population: Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure "Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better".

Outcome measures

Outcome measures
Measure	Wavefront-guided LASIK n=334 eyes LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better	98.2 percentage of eyes Interval 96.1 to 99.3

Adverse Events

Wavefront-guided LASIK

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Wavefront-guided LASIK n=334 participants at risk LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
Eye disorders Primary open angle glaucoma	0.60% 2/334 • Number of events 2 • 6 months
Eye disorders Transient light sensitivity syndrome	0.60% 2/334 • Number of events 2 • 6 months
Eye disorders Melting of the flap	0.30% 1/334 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Ann Murphy, Manager, Clinical Research

Abbott Medical Optics

Phone: 619-518-4158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The agreement between the Principal Investigator and the Sponsor (or its agents) restricts the PI's rights to discuss or publish trial results until after the trial is completed and requires prior approval from the sponsor.
Publication restrictions are in place

Restriction type: OTHER