FDA pivotal clinical study of INNOVEYES LASIK with WaveLight EX500

Evidence database / Studies / fda-innoveeyes-lasik-pivotal

168enrolled patients*

336enrolled 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

INNOVEYES LASIK

LASIKWaveLight EX500 with INNOVEYES Sightmap

Population

Patients: 168
Eyes: 336
Bilateral treatment: Yes
Age range: 21 to 56 years
Sphere range: Not reported
Cylinder range: Not reported
Spherical equivalent: Not reported
Corneal thickness: Not reported

Eligibility definition

Inclusion
Age at least 18 years; myopia up to -11.00 D with or without astigmatism up to -4.50 D; spherical equivalent no more than -12.00 D by Sightmap measured refraction; preoperative BCDVA 20/20 or better; stable refraction.

Exclusion
See FDA SSED page 9 for the complete 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	326 eyes	92.3%	301 / 326 eyes	VERIFIED Source · 25
MRSE within ±0.50 D predictability	3 months	326 eyes	92.0%	300 / 326 eyes	VERIFIED Source · 23
Refraction within ±1.00 D efficacy	3 months	326 eyes	98.5%	321 / 326 eyes	VERIFIED Source · 23
Lost at least 2 lines of CDVA safety	3 months	326 eyes	0%	0 / 330 eyes	VERIFIED Source · 15
UDVA 20/20 or better efficacy	6 months	330 eyes	91.5%	302 / 330 eyes	VERIFIED Source · 25
MRSE within ±0.50 D predictability	6 months	330 eyes	90.9%	300 / 330 eyes	VERIFIED Source · 24
Refraction within ±1.00 D efficacy	6 months	330 eyes	98.2%	324 / 330 eyes	VERIFIED Source · 24
UDVA 20/20 or better efficacy	12 months	322 eyes	94.4%	304 / 322 eyes	VERIFIED Source · 25
MRSE within ±0.50 D predictability	12 months	322 eyes	94.4%	304 / 322 eyes	VERIFIED Source · 24
Refraction within ±1.00 D efficacy	12 months	322 eyes	99.7%	321 / 322 eyes	VERIFIED Source · 24

Complications

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

Study design

Prospective, single-arm, multicenter, unmasked interventional study at 9 U.S. sites with 12 months of follow-up.

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. Values are transcribed only from identified FDA SSED tables; denominators vary by visit and analysis set.

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.