FDA pivotal clinical study of PRK with the ALLEGRETTO WAVE EYE-Q

Evidence database / Studies / fda-allegretto-eye-q-prk-pivotal

161enrolled patients*

320enrolled eyes*

1structured arms

365maximum standardized days follow-up

* Descriptive sum of reported arm counts. “≥” indicates that one or more arm counts were not reported; missing values are not treated as zero.

Study arm

ALLEGRETTO WAVE EYE-Q PRK

PRKALLEGRETTO WAVE EYE-Q

Population

Patients: 161
Eyes: 320
Bilateral treatment: Not reported
Age range: 19 to 56 years
Sphere range: Not reported
Cylinder range: Not reported
Spherical equivalent: -6 to -0.75 D
Corneal thickness: Not reported

Eligibility definition

Inclusion
Myopia or myopia with astigmatism treated for elimination of up to -6.0 D spherical equivalent, with up to -6.0 D sphere and up to -3.0 D astigmatism at the spectacle plane.

Exclusion
See FDA SSED for the complete clinical inclusion and exclusion criteria.

Reported outcomes by follow-up

Outcome	Follow-up	Follow-up sample	Result	Reported fraction	Provenance
UDVA 20/20 or better efficacy	3 months	317 eyes	90.9%	288 / 317 eyes	VERIFIED Source · 29
MRSE within ±0.50 D predictability	3 months	317 eyes	92.4%	293 / 317 eyes	VERIFIED Source · 27
Refraction within ±1.00 D efficacy	3 months	317 eyes	99.4%	315 / 317 eyes	VERIFIED Source · 27
Lost at least 2 lines of CDVA safety	3 months	317 eyes	0.30%	1 / 317 eyes	VERIFIED Source · 16
UDVA 20/20 or better efficacy	6 months	314 eyes	93.0%	292 / 314 eyes	VERIFIED Source · 29
MRSE within ±0.50 D predictability	6 months	314 eyes	93.3%	293 / 314 eyes	VERIFIED Source · 27
Refraction within ±1.00 D efficacy	6 months	314 eyes	99.7%	313 / 314 eyes	VERIFIED Source · 27
Lost at least 2 lines of CDVA safety	6 months	314 eyes	0%	0 / 314 eyes	VERIFIED Source · 16
UDVA 20/20 or better efficacy	12 months	311 eyes	94.5%	294 / 311 eyes	VERIFIED Source · 29
MRSE within ±0.50 D predictability	12 months	311 eyes	94.5%	294 / 311 eyes	VERIFIED Source · 28
Refraction within ±1.00 D efficacy	12 months	311 eyes	99.4%	309 / 311 eyes	VERIFIED Source · 28
Lost at least 2 lines of CDVA safety	12 months	311 eyes	0%	0 / 311 eyes	VERIFIED Source · 16

Complications

No structured complication observations are available for this arm. This means “not reported in this dataset,” not zero complications.

Study design

Prospective, multicenter, single-arm, open-label study at 8 U.S. sites; the FDA report describes a planned 24-month study and reports the pivotal outcomes through 12 months.

Country: United States
Publication-reported places: Not reported
Multicenter: Yes
Prospective: Yes
Randomized: No
Source type: FDA PIVOTAL
Regulator: FDA

Place metadata may refer to a treatment site, institution or author affiliation. Confirm its role in the linked publication.

Limitations and notes

Regulatory clinical-study report under IDE G120133. Values are transcribed from the FDA intent-to-treat tables without imputing missing observations.

Missing fields are not interpreted as negative findings. Arm counts may not be additive in all study designs.

Study evidence level
A simple, non-GRADE hierarchy based on design: randomized and large regulatory trials are high; prospective cohorts moderate; retrospective observational studies low. Manual review can override this label.