Trial Outcomes & Findings for Clinical Investigation of the WaveLight® EX500 Excimer Laser (NCT NCT04805593)
NCT ID: NCT04805593
Last Updated: 2024-08-21
Results Overview
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. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.
COMPLETED
NA
44 participants
Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)
2024-08-21
Participant Flow
Participants were recruited from 5 investigative sites located in 1 country (US).
Of the 44 enrolled, 14 participants were discontinued as screen failures prior to attempted surgery. This reporting group includes all enrolled participants/eyes with attempted surgery (30/60, respectively).
Unit of analysis: eyes
Participant milestones
| Measure |
WaveLight EX500 Excimer Laser System
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
|
|---|---|
|
Overall Study
STARTED
|
30 60
|
|
Overall Study
COMPLETED
|
30 60
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Investigation of the WaveLight® EX500 Excimer Laser
Baseline characteristics by cohort
| Measure |
WaveLight EX500 Excimer Laser System
n=30 Participants
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
|
|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)Population: Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit.
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. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 0.50 D was reported. Both eyes contributed data to this analysis.
Outcome measures
| Measure |
WaveLight EX500 Excimer Laser System
n=60 eyes
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
|
|---|---|
|
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within ±0.50 Diopter (D) at Refractive Stability
|
98.3 percentage of eyes
|
PRIMARY outcome
Timeframe: Up to Month 12 postoperative (Month 1 to Month 3, Month 3 to Month 6, Month 6 to Month 9, and Month 9 to Month 12)Population: Full Analysis Set (FAS) included all eyes with successful refractive surgery having at least 1 postoperative visit.
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. Refractive stability was defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. For this endpoint, change in MRSE by less than or equal to 1.00 D was reported. Both eyes contributed data to this analysis.
Outcome measures
| Measure |
WaveLight EX500 Excimer Laser System
n=60 eyes
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
|
|---|---|
|
Percentage of Eyes With MRSE Within ±1.00 D at Refractive Stability
|
100.0 percentage of eyes
|
PRIMARY outcome
Timeframe: Up to Month 12 postoperativePopulation: Safety Analysis Set: all eyes for which refractive surgery was attempted with the test device (regardless of success or failure).
An AE 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). Ocular adverse events were collected for this outcome measure. No hypothesis testing was prespecified for this endpoint.
Outcome measures
| Measure |
WaveLight EX500 Excimer Laser System
n=60 eyes
Laser-assisted in situ keratomileusis (LASIK) surgery using the WaveLight EX500 excimer laser system
|
|---|---|
|
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
Diplopia
|
11.7 percentage of eyes
|
|
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
Photophobia
|
6.7 percentage of eyes
|
|
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
Visual acuity reduced
|
3.3 percentage of eyes
|
|
Percentage of Eyes Experiencing Ocular Adverse Events (AEs)
Ocular hyperaemia
|
1.7 percentage of eyes
|
Adverse Events
Pretreament
WaveLight EX500 Excimer Laser System - Ocular
WaveLight EX500 Excimer Laser System - Systemic
Serious adverse events
| Measure |
Pretreament
n=30 participants at risk
AEs in this group occurred prior to treatment with the WaveLight EX500 excimer laser system.
|
WaveLight EX500 Excimer Laser System - Ocular
n=60 participants at risk
AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include ocular events in the study eye.
|
WaveLight EX500 Excimer Laser System - Systemic
n=30 participants at risk
AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include overall systemic events.
|
|---|---|---|---|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/30 • 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.
|
3.3%
2/60 • 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.
|
0.00%
0/30 • 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.
|
Other adverse events
| Measure |
Pretreament
n=30 participants at risk
AEs in this group occurred prior to treatment with the WaveLight EX500 excimer laser system.
|
WaveLight EX500 Excimer Laser System - Ocular
n=60 participants at risk
AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include ocular events in the study eye.
|
WaveLight EX500 Excimer Laser System - Systemic
n=30 participants at risk
AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include overall systemic events.
|
|---|---|---|---|
|
Eye disorders
Diplopia
|
0.00%
0/30 • 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.
|
11.7%
7/60 • 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.
|
0.00%
0/30 • 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.
|
|
Eye disorders
Photophobia
|
0.00%
0/30 • 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.
|
6.7%
4/60 • 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.
|
0.00%
0/30 • 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.
|
Additional Information
Clinical Projects Director, Surgical
Alcon Research, LLC
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