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Postmarket Study of outcomes from WaveLight® EX500 InnovEyes™ treatment in conjunction with the InnovEyes™ Sightmap

Postmarket Study of outcomes from WaveLight® EX500 InnovEyes™ treatment in conjunction with the InnovEyes™ Sightmap - RFP911-P001

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00020388
Enrollment
120
Registered
2020-03-12
Start date
2020-07-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H52.2 H52.1

Interventions

Group 1: WaveLight EX500 using InnovEyes in conjunction with InnovEyes Sightmap

Sponsors

Alcon Research, LLC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to No maximum

Inclusion criteria

Inclusion criteria: - Minimum of 21 years of age - Myopia up to and including -11.00 D with or without astigmatism up to -4.50 D - BCDVA of 20/20 or better Other protocol-defined inclusion criteria may apply

Exclusion criteria

Exclusion criteria: - Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study. - Previous intraocular or corneal surgery - Participation in other clinical trials during the course of the study that may confound study results Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

MeasureTime frame
Percentage of eyes with absolute MRSE within ±0.25, ±0.50, ±0.75 and ±1.00 D at 3 months postoperative

Countries

Australia, Germany, Greece

Contacts

Public ContactMaria Jockovich

Alcon Research, LLC

alcon.medinfo@alcon.com1-888-451-3937

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026