Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

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Status

Completed

Conditions

Refractive Error - Myopia Simple
Refractive Error - Myopia Severe

Treatments

Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System
Procedure: Laser Assisted Lenticular Extraction

Study type

Interventional

Funder types

Industry

Identifiers

NCT03021707
RFO268-E001

Details and patient eligibility

About

The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.

Enrollment

7 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Photopic distance visual acuity worse than best corrected visual acuity (BCVA) 20/400 in the study eye;
  • Myopia with manifest refraction spherical equivalent (MRSE) of - 1.50 diopter (D) or higher in the study eye;
  • Able to comprehend and provide documented informed consent;
  • Willing and able to comply with schedule for follow-up visits;
  • Minimum required endothelial cell density (ECD) in study eye as outlined in the protocol;
  • Presence of natural lens in study eye;
  • A treatment simulation with spectacles or contact lenses on the study eye does not negatively impact participant's daily activities;
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Pregnant or nursing;
  • Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study as clinically assessed by the Investigator;
  • Active implanted device, including but not limited to, heart pacemaker or defibrillator, for which laser use may be a contraindication;
  • Current use of medications with known ocular side effects;
  • Predicted residual stromal bed thickness <300 micrometers (μm) in study eye
  • Ocular conditions in the study eye;
  • Previous ocular surgery in the study eye that resulted in corneal distortions within the treatment zone;
  • Residual, recurrent or active ocular disease that may impact study outcomes;
  • Previous or current diagnosis of dry eye;
  • Known allergic reaction to medications expected to be used preoperatively, during laser refractive surgery, and for postoperative care;
  • Pre-existing corneal opacities in study eye;
  • Contact lens worn in study eye and not removed prior to study testing affected by wear per timeframe specified in the protocol;
  • Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

UV-FS laser
Experimental group
Description:
WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant)
Treatment:
Procedure: Laser Assisted Lenticular Extraction
Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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