Creating LASIK Flaps With the LenSx Femtosecond Laser

Alcon

Status and phase: Completed; Phase 1

Conditions: Myopia; Hyperopia

Treatments: Device: LenSx Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01556893

CS-004f

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Must have myopia or hyperopia eligible for femtosecond initiated LASIK surgery
2. Must be over 18 years of age
3. Must have visual acuity correctable to at least 20/25 in both eyes
4. 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)
5. Must be willing and able to return for scheduled follow up examinations through 3 months after surgery
6. Must sign and be given a copy of the written Informed Consent form
7. Postoperative refractive target is emmetropia

Exclusion criteria

1. Known sensitivity to planned study concomitant medications
2. Participation in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
3. Presenting any contraindications to femtosecond initiated LASIK
4. Corneal thickness values that will result in residual bed less than 280 microns when flap resection and excimer ablation are calculated
5. Irregular astigmatism, based on Investigator's judgment
6. Undergoing monovision LASIK
7. Pregnant, lactating or plan to become pregnant during the course of this study
8. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

LASIK Flap Arm

Other group

Description:

This is a single arm study.

Treatment:

Device: LenSx Laser