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

The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Procedure: LASIK surgery; Device: Femtosecond Laser System

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LenSx; LASIK surgery in both eyes using LenSx® Femtosecond Laser System	Procedure: LASIK surgery; Device: Femtosecond Laser System; Used for the creation of a corneal flap in patients undergoing LASIK surgery; Other Names: LenSx®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 3 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 1 postoperative
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.	Month 1, Month 3 postoperative
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.	Day 0, operative day
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.	Day 0, operative day
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.	Day 0, operative day
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.	Month 1, Month 3 postoperative
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.	Baseline, Month 1, Month 3 postoperative
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.	Baseline, Month 1, Month 3 postoperative
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	Month 1, Month 3 postoperative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Manager, GCRA, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2015
• Primary Completion (Actual): April 9, 2016
• Study Completion (Actual): April 9, 2016

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CTJ121-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes