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Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

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ClinicalTrials.gov Identifier: NCT02575911
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : May 24, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Device: Femtosecond Laser System Procedure: LASIK surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Actual Study Start Date : October 28, 2015
Actual Primary Completion Date : April 9, 2016
Actual Study Completion Date : April 9, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: LenSx
LASIK surgery in both eyes using LenSx® Femtosecond Laser System
 Device: Femtosecond Laser System
Used for the creation of a corneal flap in patients undergoing LASIK surgery
Other Name: LenSx®

Procedure: LASIK surgery


Outcome Measures
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Primary Outcome Measures :
  1. Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative [ Time Frame: 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 :
  1. Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative [ Time Frame: 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.

  2. Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative [ Time Frame: Month 1, 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.

  3. Ease of Flap Dissection at Day 0, Operative Day [ Time Frame: 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.

  4. Stromal Bed Quality at Day 0, Operative Day [ Time Frame: 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.

  5. Opaque Bubble Layer (OBL) at Day 0, Operative Day [ Time Frame: 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.

  6. Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative [ Time Frame: Month 1, 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.

  7. Best Corrected Distance Visual Acuity (BCDVA) by Visit [ Time Frame: Baseline, Month 1, Month 3 postoperative ]
    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.

  8. Manifest Refraction Spherical Equivalent (MRSE) [ Time Frame: Baseline, Month 1, Month 3 postoperative ]
    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.

  9. Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op [ Time Frame: Month 1, Month 3 postoperative ]
    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


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575911


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Trial Manager, GCRA Alcon, A Novartis Division
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02575911    
Other Study ID Numbers: CTJ121-P001
First Posted: October 15, 2015    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: July 2, 2018
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases