Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

March 30, 2022 updated by: Alcon Research
The purpose of this study is to evaluate the initial safety of the UV-FS laser in humans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to Month 6 (post-operative)
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.
Screening, Up to Month 6 (post-operative)
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.
Screening, Up to Month 6 (post-operative)
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.
Screening, Up to Month 6 (post-operative)
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.
Screening, Up to Month 6 (post-operative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Manager, Surgical, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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