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

Alcon Research34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia Hyperopia

Interventions

Femtosecond Laser SystemDEVICE

Used for the creation of a corneal flap in patients undergoing LASIK surgery

LASIK surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Month 3 postoperative

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Day 0, operative day

Stromal Bed Quality at Day 0, Operative Day

Data from ClinicalTrials.gov

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