Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

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

Study Overview

• Status: Completed
• Conditions: Refractive Error - Myopia Severe; Refractive Error - Myopia Simple
• Intervention / Treatment: Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System; Procedure: Laser Assisted Lenticular Extraction

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 18
    • Alcon Investigative Site
• Singapore
  • Singapore, Singapore, 168751
    • Alcon Investigative Site
• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Alcon Investigative Site
  • Texas
    • Houston, Texas, United States, 77027
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: UV-FS laser; WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant)	Device: WaveLight® Ultraviolet Femtosecond (FS) Laser System; Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction; Other Names: Model 1026; UV-FS laser; Procedure: Laser Assisted Lenticular Extraction; Used for refractive error correction; Other Names: UV-Femto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of optical treatment zone corneal haze	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.	Up to Month 6 (post-operative)
Mean change from screening in presence of disruption in the integrity of retinal layers in the macula	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.	Screening, Up to Month 6 (post-operative)
Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure	Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.	Screening, Up to Month 6 (post-operative)
Mean percentage change in lens opacification from screening to each visit post procedure	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.	Screening, Up to Month 6 (post-operative)
Mean percentage change in foveal thickness from screening to each visit post procedure	Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.	Screening, Up to Month 6 (post-operative)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, Surgical, Alcon Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2017
• Primary Completion (ACTUAL): May 27, 2019
• Study Completion (ACTUAL): October 17, 2019

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (ESTIMATE): January 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: RFO268-E001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes