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UV-Femtosecond Laser Assisted Lenticule Extraction Astigmatism Nomogram Study in Subjects with Myopia

UV-Femtosecond Laser Assisted Lenticule Extraction Astigmatism Nomogram Study in Subjects with Myopia - RFO268-C004

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035333
Enrollment
80
Registered
2024-10-30
Start date
2024-11-05
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

H52.1

Interventions

Group 1: It is refractive laser surgical procedure with the WaveLight® Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) lasting approximately 5 minutes. It is a 2 step procedure where in

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 bis -10,00 dpt and cylinder -0,25 bis 2,00 dpt (as measured by pretreatment manifest refraction) in the study eye are eligible to participate on 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 would increase the operative risk

Design outcomes

Primary

MeasureTime frame
Astigmatism subjective manifest refraction at postoperative follow-up visits in week 1, month 1, month 3 and month 6

Secondary

MeasureTime frame
• Spherical subjective (manifest dry) refraction at postoperative follow-up visits • Uncorrected distance visual acuity at all follow-up visits • Manifest refraction spherical equivalent at postoperative follow-up visits

Countries

Germany, India

Outcome results

None listed

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