Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-07

Study Completion Date

2019-10-17

Brief Summary

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

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Detailed Description

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Conditions

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Refractive Error - Myopia Severe Refractive Error - Myopia Simple

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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UV-FS laser

WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant)

Group Type EXPERIMENTAL

WaveLight® Ultraviolet Femtosecond (FS) Laser System

Intervention Type DEVICE

Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction

Laser Assisted Lenticular Extraction

Intervention Type PROCEDURE

Used for refractive error correction

Interventions

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WaveLight® Ultraviolet Femtosecond (FS) Laser System

Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction

Intervention Type DEVICE

Laser Assisted Lenticular Extraction

Used for refractive error correction

Intervention Type PROCEDURE

Other Intervention Names

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Model 1026 UV-FS laser UV-Femto

Eligibility Criteria

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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;

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;

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No