Trial Outcomes & Findings for WaveLight® EX500 Excimer Laser System for the Correction of Myopia Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap (NCT NCT04219891)

Results Overview

Visual acuity (VA) was assessed using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters and reported in Snellen, where 20/20 indicates normal distance eyesight. Preoperatively, VA was assessed with correction in place. Postoperatively, VA was assessed with no correction in place. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

272 participants

Primary outcome timeframe

Preoperative Visit (Day -30 to Day -1), Month 1, Month 3

Results posted on

2025-04-06

Participant Flow

Participants were recruited from 9 investigative sites located in 1 country (US).

Of the 272 enrolled, 104 participants were exited prior to treatment as screen failures. This reporting group includes all subjects with attempted surgery (168 subjects / 336 eyes).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	WaveLight EX500 Excimer Laser System Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Overall Study STARTED	168 336
Overall Study Successful Surgery	168 336
Overall Study Safety Analysis Set (SAS)	168 336
Overall Study Full Analysis Set (FAS)	167 334
Overall Study FAS at Refractive Stability	163 236
Overall Study COMPLETED	163 326
Overall Study NOT COMPLETED	5 10

Reasons for withdrawal

Reasons for withdrawal
Measure	WaveLight EX500 Excimer Laser System Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

WaveLight® EX500 Excimer Laser System for the Correction of Myopia Using InnovEyes™ in Conjunction With InnovEyes™ Sightmap

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WaveLight EX500 Excimer Laser System n=334 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Age, Continuous	33.3 years STANDARD_DEVIATION 6.98 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants
Race/Ethnicity, Customized White	128 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	16 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Multi-Racial	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	23 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	143 Participants n=5 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3

Population: FAS. Note: 1 eye was excluded from this analysis due to not having a preoperative best corrected distance visual acuity (BCDVA) of 20/20 or better.

Visual acuity (VA) was assessed using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters and reported in Snellen, where 20/20 indicates normal distance eyesight. Preoperatively, VA was assessed with correction in place. Postoperatively, VA was assessed with no correction in place. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=325 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/40 or Better (in Eyes With Preoperative Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better) at Refractive Stability	100.0 percentage of eyes

PRIMARY outcome

Timeframe: Month 1, Month 3

Population: FAS

A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive Stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=326 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes With Manifest Refractive Spherical Equivalent (MRSE) Within +/- 0.50 Diopter (D) at Refractive Stability	92.0 percentage of eyes

PRIMARY outcome

Timeframe: Month 1, Month 3

Population: FAS

A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=326 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes With MRSE Within +/- 1.00 D at Refractive Stability	98.5 percentage of eyes

PRIMARY outcome

Timeframe: Preoperative Visit (Day -30 to Day -1), Month 1, Month 3

Population: Consistent Cohort Analysis Set: All eyes in the FAS that have manifest refraction data at all post-operative visits from one month up to and including the visit where refractive stability is established.

A manifest refraction (manual refraction) was performed using a phoropter. The spherical equivalent was calculated by adding the sum of the sphere power with half of the cylinder power and reported in diopters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A higher percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=326 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes That Achieve Refractive Stability Assessed as Change From Baseline in MRSE of Equal to or Less Than 1.0 D	99.4 percentage of eyes

PRIMARY outcome

Timeframe: Day -30 to -1 (preoperative), up to Month 3

Population: SAS with requisite data at Month 3. Note: 1 eye was excluded from this analysis due to not having a preoperative BCDVA of 20/20 or better.

VA was assessed using ETDRS charts at a distance of 4 meters with correction in place. BCDVA was measured in Snellen, where 20/20 indicates normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=329 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes With BCDVA Worse Than 20/40 (With BCDVA 20/20 or Better Preoperatively) at Refractive Stability	0.0 percentage of eyes

PRIMARY outcome

Timeframe: Day -30 to -1 (preoperative), up to Month 3

Population: SAS with requisite data at Month 3

VA was assessed using ETDRS charts at a distance of 4 meters with correction in place and measured in logarithm Minimum Angle of Resolution, where each line on the letter chart represents 0.1 Snellen and 0.0 logMAR equates to 20/20 Snellen, or normal distance eyesight. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=330 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes With BCDVA Loss of 2 Lines (10 Letters) or More From Preoperative Visit at Refractive Stability	0 percentage of eyes

PRIMARY outcome

Timeframe: Day -30 to -1 (preoperative), up to Month 3

Population: SAS with requisite data at Month 3

Manifest refractive astigmatism is the cylindrical portion of the subjective refraction. It is measured with ETDRS charts at a distance of 4 meters. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=330 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes With Increase of Manifest Refractive Astigmatism Greater Than 2.00 Diopter (D) of Absolute Cylinder Compared to Preoperative Visit at Refractive Stability	0.0 percentage of eyes

PRIMARY outcome

Timeframe: Up to Month 3

Population: SAS with requisite data at Month 3

An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test product). Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at Month 3 after surgery when compared with the Month 1 visit) that meets all the protocol-specified stability requirements. Refractive stability was considered to be achieved at the Month 3 visit. A lower percentage indicates a better outcome. Both eyes contributed data to this analysis. No hypothesis testing was pre-specified for this endpoint. This is a co-primary endpoint.

Outcome measures

Outcome measures
Measure	WaveLight EX500 Excimer Laser System n=330 eyes Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap
Percentage of Eyes With Non-flap Related Ocular Serious Adverse Events at Refractive Stability	0.0 percentage of eyes

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

WaveLight EX500 Excimer Laser System (Ocular)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

WaveLight EX500 Excimer Laser System (Systemic)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=168 participants at risk AEs in this group occurred prior to treatment with the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap	WaveLight EX500 Excimer Laser System (Ocular) n=336 participants at risk AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap and include ocular events in the study eye	WaveLight EX500 Excimer Laser System (Systemic) n=168 participants at risk AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap and include overall systemic events
Eye disorders Retinal Tear	0.00% 0/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	0.60% 2/336 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	0.00% 0/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.
Eye disorders Visual acuity reduced	0.00% 0/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	0.60% 2/336 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	0.00% 0/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.
Eye disorders Corneal opacity	0.00% 0/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	0.30% 1/336 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	0.00% 0/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.

Other adverse events

Other adverse events
Measure	Pretreatment n=168 participants at risk AEs in this group occurred prior to treatment with the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap	WaveLight EX500 Excimer Laser System (Ocular) n=336 participants at risk AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap and include ocular events in the study eye	WaveLight EX500 Excimer Laser System (Systemic) n=168 participants at risk AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser with InnovEyes software in conjunction with InnovEyes sightmap and include overall systemic events
Infections and infestations Corona virus infection	1.8% 3/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	0.00% 0/336 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.	6.0% 10/168 • Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year. AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.

Additional Information

Clinical Projects Director, Surgical

Alcon Research, LLC

Phone: 8884513937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to study.
Publication restrictions are in place

Restriction type: OTHER