Trial Outcomes & Findings for A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System (NCT NCT01699087)

NCT ID: NCT01699087

Last Updated: 2019-09-30

Results Overview

Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 176 participants
• Primary outcome timeframe: Month 6 (post second eye surgery)
• Results posted on: 2019-09-30

Participant Flow

Participants were recruited from 8 investigative sites located in the United States.

Of the 176 participants enrolled, 15 did not meet inclusion and exclusion criteria and were exited prior to treatment as screen failures.

Participant milestones

Measure	PRK ALLEGRETTO Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Overall Study STARTED	176
Overall Study Treated	161
Overall Study COMPLETED	152
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	PRK ALLEGRETTO Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Overall Study Lost to Follow-up	7
Overall Study Screen failure (prior to treatment)	15
Overall Study Unable to make future visits	2

Baseline Characteristics

A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System

Baseline characteristics by cohort

Measure	PRK ALLEGRETTO n=161 Participants Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Age, Continuous	31.5 years STANDARD_DEVIATION 7.4 • n=93 Participants
Sex: Female, Male Female	72 Participants n=93 Participants
Sex: Female, Male Male	89 Participants n=93 Participants
Region of Enrollment United States	161 participants n=93 Participants

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: Intent to treat (ITT)

Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.

Outcome measures

Measure	PRK ALLEGRETTO n=294 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively	100 percentage of eyes

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: ITT

Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.

Outcome measures

Measure	PRK ALLEGRETTO n=314 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability	99.7 percentage of eyes

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: ITT

Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.

Outcome measures

Measure	PRK ALLEGRETTO n=314 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability	93.3 percentage of eyes

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: ITT

Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.

Outcome measures

Measure	PRK ALLEGRETTO n=314 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability	99.0 percentage of eyes

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: ITT

Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.

Outcome measures

Measure	PRK ALLEGRETTO n=314 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability	92.7 percentage of eyes

PRIMARY outcome

Timeframe: Up to Month 24 (post second eye surgery)

Population: ITT

MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.

Outcome measures

Measure	PRK ALLEGRETTO n=320 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits Month 3 to Month 6	99.7 percentage of eyes
Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits Month 6 to Month 9	100 percentage of eyes
Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits Month 12 to Month 24	100 percentage of eyes
Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits Week 1 to Month 1	90.9 percentage of eyes
Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits Month 1 to Month 3	95.6 percentage of eyes
Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits Month 9 to Month 12	99.7 percentage of eyes

PRIMARY outcome

Timeframe: Up to Month 24 (post second eye surgery)

Population: ITT

Participants were followed for the duration of the study, an expected average of 24 months.

Outcome measures

Measure	PRK ALLEGRETTO n=320 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Cumulative Incidence of Ocular Serious Adverse Events by Eye Corneal infiltrates	2 eyes
Cumulative Incidence of Ocular Serious Adverse Events by Eye Corneal oedema	1 eyes

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: ITT

Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).

Outcome measures

Measure	PRK ALLEGRETTO n=314 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability	0.0 percentage of eyes

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: ITT

Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .

Outcome measures

Measure	PRK ALLEGRETTO n=320 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability	0.0 percentage of eyes

PRIMARY outcome

Timeframe: Month 6 (post second eye surgery)

Population: ITT

Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.

Outcome measures

Measure	PRK ALLEGRETTO n=320 eyes Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability	0.0 percentage of eyes

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRK ALLEGRETTO

Serious events: 6 serious events

Other events: 123 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pre-treatment n=176 participants at risk All subjects who consented to participate in the study prior to the initiation of study treatment	PRK ALLEGRETTO n=161 participants at risk All subjects who underwent PRK surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Eye disorders Corneal infiltrates	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	1.2% 2/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Eye disorders Corneal oedema	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	0.62% 1/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	0.62% 1/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Infections and infestations Appendicitis	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	0.62% 1/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	0.62% 1/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	0.62% 1/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.

Other adverse events

Measure	Pre-treatment n=176 participants at risk All subjects who consented to participate in the study prior to the initiation of study treatment	PRK ALLEGRETTO n=161 participants at risk All subjects who underwent PRK surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
Eye disorders Corneal opacity	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	7.5% 12/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Eye disorders Diplopia	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	27.3% 44/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Eye disorders Dry eye	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	26.1% 42/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Eye disorders Eye pain	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	39.1% 63/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Eye disorders Foreign body sensation in eyes	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	50.9% 82/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.
Eye disorders Photophobia	0.00% 0/176 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.	8.1% 13/161 • Adverse events (AEs) were collected from time of consent through the duration of a subject's participation in the study (up to 29 months). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained as solicited comments from study participants and as observations by the Investigator as outlined in the study protocol.

Additional Information

Expert Clinical Project Lead, GCRA, Surgical

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

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 the study
• Publication restrictions are in place

Restriction type: OTHER