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Creating LASIK Flaps With the LenSx Femtosecond Laser

Primary Purpose

Myopia, Hyperopia

Status
Completed
Phase
Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
LenSx Laser
Sponsored by
Alcon LenSx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Flap Creation, Femtosecond Laser, corneal flap prior to LASIK procedure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
  2. Must be over 18 years of age
  3. Must have visual acuity correctable to at least 20/25 in both eyes
  4. If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
  5. Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
  6. Must sign and be given a copy of the written Informed Consent form
  7. Postoperative refractive target is emmetropia

Exclusion Criteria:

  1. Known sensitivity to planned study concomitant medications
  2. Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
  3. Presenting any contraindications to femtosecond initiated LASIK
  4. Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
  5. Irregular astigmatism, based on Investigator's judgment
  6. Undergoing monovision LASIK
  7. Pregnant, lactating or plan to become pregnant during the course of this study
  8. For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.

Sites / Locations

  • Department of Ophthalmology, Semmelweis University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LASIK Flap Arm

Arm Description

This is a single arm study.

Outcomes

Primary Outcome Measures

Ease of Lifting Flaps
0 - Unable to lift flap - Able to lift flap with aid of sharp instrument - Able to lift flap with difficulty using blunt instrument - Able to lift flap with moderate resistance using blunt instrument - Able to lift flap with minimal resistance using blunt instrument - Able to lift flap without any resistance using blunt instrument (Scale)

Secondary Outcome Measures

Stromal Bed Quality
0 - very rough 1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)

Full Information

First Posted
March 15, 2012
Last Updated
October 23, 2014
Sponsor
Alcon LenSx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01556893
Brief Title
Creating LASIK Flaps With the LenSx Femtosecond Laser
Official Title
Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon LenSx, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility. Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment. Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
Keywords
Flap Creation, Femtosecond Laser, corneal flap prior to LASIK procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LASIK Flap Arm
Arm Type
Other
Arm Description
This is a single arm study.
Intervention Type
Device
Intervention Name(s)
LenSx Laser
Intervention Description
The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647).
Primary Outcome Measure Information:
Title
Ease of Lifting Flaps
Description
0 - Unable to lift flap - Able to lift flap with aid of sharp instrument - Able to lift flap with difficulty using blunt instrument - Able to lift flap with moderate resistance using blunt instrument - Able to lift flap with minimal resistance using blunt instrument - Able to lift flap without any resistance using blunt instrument (Scale)
Time Frame
Operative
Secondary Outcome Measure Information:
Title
Stromal Bed Quality
Description
0 - very rough 1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)
Time Frame
Operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery Must be over 18 years of age Must have visual acuity correctable to at least 20/25 in both eyes If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses) Must be willing and able to return for scheduled follow up examinations through 3 months after surgery Must sign and be given a copy of the written Informed Consent form Postoperative refractive target is emmetropia Exclusion Criteria: Known sensitivity to planned study concomitant medications Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation Presenting any contraindications to femtosecond initiated LASIK Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated Irregular astigmatism, based on Investigator's judgment Undergoing monovision LASIK Pregnant, lactating or plan to become pregnant during the course of this study For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.
Facility Information:
Facility Name
Department of Ophthalmology, Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary

12. IPD Sharing Statement

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Creating LASIK Flaps With the LenSx Femtosecond Laser

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