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UV Femtosecond Laser Assisted Lenticule Extraction Sphere Nomogram Study

UV Femtosecond Laser Assisted Lenticule Extraction Sphere Nomogram Study - RFO268-C001

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031788
Enrollment
45
Registered
2023-05-23
Start date
2023-09-28
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

H52.1

Interventions

Group 1: WaveLight® Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser)

Sponsors

Alcon Research, LLC,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Subjects of either sex who are at least 18 years of age or older with Myopia with sphere of -0.50 to -10.0 D and cylinder = -0.5 D (as measured by pretreatment manifest refraction) in study eye are eligible to participate in the study.

Exclusion criteria

Exclusion criteria: Subjects whose study eye is unable to focus for imaging and/or treatment or subjects who have acute or chronic disease or illness that would increase the operative risk

Design outcomes

Primary

MeasureTime frame
Spherical manifest refraction (MRX) at postoperative follow-up visits at Week 1, Month 1, Month 3 und Month 6

Secondary

MeasureTime frame
• Cylinder MRX at postoperative follow-up visits • Uncorrected distance visual acuity at postoperative follow-up visits • Manifest refraction spherical equivalent at postoperative follow-up visits

Countries

Germany, India

Contacts

Public ContactStephanie Bröcker

Alcon Deutschland GmbH

Stephanie.Broecker@alcon.com+49 761 1304 226

Outcome results

None listed

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