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Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

Primary Purpose

Refractive Error - Myopia Severe, Refractive Error - Myopia Simple

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WaveLight® Ultraviolet Femtosecond (FS) Laser System
Laser Assisted Lenticular Extraction
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Refractive Error - Myopia Severe

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site
  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UV-FS laser

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2017
Last Updated
March 30, 2022
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03021707
Brief Title
Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
Official Title
Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error - Myopia Severe, Refractive Error - Myopia Simple

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UV-FS laser
Arm Type
Experimental
Arm Description
WaveLight® Ultraviolet Femtosecond Laser System during UV-Femto, single session (one treatment per eye per participant)
Intervention Type
Device
Intervention Name(s)
WaveLight® Ultraviolet Femtosecond (FS) Laser System
Other Intervention Name(s)
Model 1026, UV-FS laser
Intervention Description
Utilizes ultraviolet (UV) light with a wavelength of 347 nanometers (nm) for refractive error correction
Intervention Type
Procedure
Intervention Name(s)
Laser Assisted Lenticular Extraction
Other Intervention Name(s)
UV-Femto
Intervention Description
Used for refractive error correction
Primary Outcome Measure Information:
Title
Presence of optical treatment zone corneal haze
Description
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.
Time Frame
Up to Month 6 (post-operative)
Title
Mean change from screening in presence of disruption in the integrity of retinal layers in the macula
Description
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.
Time Frame
Screening, Up to Month 6 (post-operative)
Title
Mean percentage change in average endothelial cell density (ECD) from screening to each visit post procedure
Description
Specular microscopy will be performed on the study eye and endothelial cell density will be recorded.
Time Frame
Screening, Up to Month 6 (post-operative)
Title
Mean percentage change in lens opacification from screening to each visit post procedure
Description
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.
Time Frame
Screening, Up to Month 6 (post-operative)
Title
Mean percentage change in foveal thickness from screening to each visit post procedure
Description
Foveal thickness will be assessed by a posterior segment OCT scan of the study eye.
Time Frame
Screening, Up to Month 6 (post-operative)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Surgical
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Alcon Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Alcon Investigative Site
City
Dublin
ZIP/Postal Code
18
Country
Ireland
Facility Name
Alcon Investigative Site
City
Singapore
ZIP/Postal Code
168751
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Feasibility Study of UV-Femtosecond Laser Assisted Lenticular Extraction

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