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Completed

NCT Number: NCT02575911

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.

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Key information

Conditions

Myopia Eye Diseases Hyperopia Refractive Errors

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Femtosecond Laser System

Device

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

Other names: LenSx®

LASIK surgery

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 15, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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