Early Feasibility Study of UV-Femtoseco… | Clinical Trial

Key information

Conditions

Refractive Error - Myopia Severe Refractive Error - Myopia Simple

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Dublin, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WaveLight® Ultraviolet Femtosecond (FS) Laser System

Device

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

Other names: Model 1026, UV-FS laser

Laser Assisted Lenticular Extraction

Procedure

Used for refractive error correction

Other names: UV-Femto

Primary outcomes

Presence of optical treatment zone corneal haze

Time frame: Up to Month 6 (post-operative)

Corneal haze will be assessed on a scale of 0 to 4, where 0 = clear or no haze can be seen, and 4 = opacity is visible without slit lamp, greatly obscures iris detail.
Mean change from screening in presence of disruption in the integrity of retinal layers in the macula

Time frame: Screening, Up to Month 6 (post-operative)

Retinal layer integrity will be assessed by a posterior segment ocular coherence tomography (OCT) scan of the study eye. Any disruption (change) in the retinal layers in the macula as compared to the screening scan will assess retinal integrity.
Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure

Time frame: Screening, Up to Month 6 (post-operative)

Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.
Mean percentage change in lens opacification from screening to each visit post procedure

Time frame: Screening, Up to Month 6 (post-operative)

A Scheimpflug scan will be performed to evaluate any opacification of the crystalline lens in the study eye and a Pentacam Nucleus Staging (PNS) grade from 0 to 5 will be assigned.
Mean percentage change in foveal thickness from screening to each visit post procedure

Time frame: Screening, Up to Month 6 (post-operative)

Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jan 16, 2017
Registry last updated: Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.