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Completed

NCT Number: NCT01556893

Creating LASIK Flaps With the LenSx Femtosecond Laser

This will be a prospective, single-center clinical trial of up to 50 eyes of subjects scheduled to undergo LASIK surgery requiring an initial corneal flap. Subjects will be screened for eligibility.

Subjects will undergo LASIK surgery using the LenSx Laser to create the corneal flap prior to excimer laser treatment.

Subjects will be evaluated intraoperatively to assess the ease of lifting the flaps, the stromal bed quality, and the amount of opaque bubble layer. All patients will be followed with routine vision exams for 3 months postoperatively to evaluate changes in visual acuity, manifest refraction, slit lamp examination, and endothelial cell counts.

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Key information

Conditions

Myopia Eye Diseases Hyperopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Ophthalmology, Semmelweis University

Budapest, 1085, Hungary

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
  • Must be over 18 years of age
  • Must have visual acuity correctable to at least 20/25 in both eyes
  • If subject is a contact lens wearer, discontinuation of contact lens wear prior to preoperative exam (2 weeks prior for soft contact lenses, 4 weeks prior for rigid gas permeable contact lenses, and 8 weeks prior for hard contact lenses)
  • Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
  • Must sign and be given a copy of the written Informed Consent form
  • Postoperative refractive target is emmetropia

Exclusion criteria

  • Known sensitivity to planned study concomitant medications
  • Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
  • Presenting any contraindications to femtosecond initiated LASIK
  • Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
  • Irregular astigmatism, based on Investigator's judgment
  • Undergoing monovision LASIK
  • Pregnant, lactating or plan to become pregnant during the course of this study
  • For bilateral second study eyes only: The surgeon shall not proceed with the second eye until the 1 week exam of the first eye shows no vision threatening complications.

Treatment and study plan

LenSx Laser

Device

The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647).

Primary outcomes

  1. Ease of Lifting Flaps

    Time frame: Operative

    0 - Unable to lift flap

    • - Able to lift flap with aid of sharp instrument
    • - Able to lift flap with difficulty using blunt instrument
    • - Able to lift flap with moderate resistance using blunt instrument
    • - Able to lift flap with minimal resistance using blunt instrument
    • - Able to lift flap without any resistance using blunt instrument (Scale)

Secondary outcomes

  1. Stromal Bed Quality

    Time frame: Operative

    0 - very rough

    1- moderately rough 2 - rough 3 - smooth 4 - moderately smooth 5 - very smooth (Scale)

Sponsors and collaborators

Lead sponsor

Alcon LenSx, Inc.

Industry

Registry information

Official study title

Prospective, Single-center Clinical Trial of Subjects Scheduled to Undergo LASIK Surgery Requiring an Initial Corneal Flap.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2012
Registry last updated
Oct 27, 2014

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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