Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

Alcon

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

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.