Back to resultsAccuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Primary Purpose
Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Femtosecond Laser System
LASIK surgery
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
- Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
- If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
- Willing and able to return for ALL scheduled follow-up examinations;
- Willing and able to provide written informed consent;
- Eligible for bilateral LASIK procedures to be done on the same day;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
- Known sensitivity to planned study concomitant medications;
- Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
- Irregular astigmatism, based on the Investigator's judgement;
- Pregnant, lactating or planning to become pregnant during the course of the study;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LenSx
Arm Description
LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Outcomes
Primary Outcome Measures
Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Secondary Outcome Measures
Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative
Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative
Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.
Ease of Flap Dissection at Day 0, Operative Day
Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.
Stromal Bed Quality at Day 0, Operative Day
Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.
Opaque Bubble Layer (OBL) at Day 0, Operative Day
Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative
UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Best Corrected Distance Visual Acuity (BCDVA) by Visit
BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Manifest Refraction Spherical Equivalent (MRSE)
The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.
Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op
Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02575911
Brief Title
Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Official Title
Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 28, 2015 (Actual)
Primary Completion Date
April 9, 2016 (Actual)
Study Completion Date
April 9, 2016 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LenSx
Arm Type
Experimental
Arm Description
LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Intervention Type
Device
Intervention Name(s)
Femtosecond Laser System
Other Intervention Name(s)
LenSx®
Intervention Description
Used for the creation of a corneal flap in patients undergoing LASIK surgery
Intervention Type
Procedure
Intervention Name(s)
LASIK surgery
Primary Outcome Measure Information:
Title
Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
Description
Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Time Frame
Month 3 postoperative
Secondary Outcome Measure Information:
Title
Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative
Description
Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Time Frame
Month 1 postoperative
Title
Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative
Description
Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.
Time Frame
Month 1, Month 3 postoperative
Title
Ease of Flap Dissection at Day 0, Operative Day
Description
Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.
Time Frame
Day 0, operative day
Title
Stromal Bed Quality at Day 0, Operative Day
Description
Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.
Time Frame
Day 0, operative day
Title
Opaque Bubble Layer (OBL) at Day 0, Operative Day
Description
Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.
Time Frame
Day 0, operative day
Title
Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative
Description
UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Time Frame
Month 1, Month 3 postoperative
Title
Best Corrected Distance Visual Acuity (BCDVA) by Visit
Description
BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.
Time Frame
Baseline, Month 1, Month 3 postoperative
Title
Manifest Refraction Spherical Equivalent (MRSE)
Description
The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.
Time Frame
Baseline, Month 1, Month 3 postoperative
Title
Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op
Description
Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative
Time Frame
Month 1, Month 3 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
Willing and able to return for ALL scheduled follow-up examinations;
Willing and able to provide written informed consent;
Eligible for bilateral LASIK procedures to be done on the same day;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
Known sensitivity to planned study concomitant medications;
Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
Irregular astigmatism, based on the Investigator's judgement;
Pregnant, lactating or planning to become pregnant during the course of the study;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Manager, GCRA
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
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