Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Moderate to High Myopia

NCT ID: NCT00762541

Last Updated: 2018-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-07-31

Brief Summary

The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of moderate to high myopia (nearsightedness), when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.

Detailed Description

LASIK has become one of the most common refractive eye procedures performed in the country. Currently the MEL 80 Excimer Laser System is approved for the elimination of myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a maximum MRSE of -7.00 D. The goal of this study is to assess the safety and effectiveness information on the treatment of moderate to high magnitudes of myopia.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MEL 80 Treatment of High Myopia

The reduction or elimination of myopia \> -7.00 D to -12.00 D, and astigmatism less than or equal to -6.00 D at the spectacle plane (myopia with or without astigmatism), with a maximum MRSE ≤ -12.00 D.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Myopia > -7.00 D to -12.00 D, and astigmatism less than or equal to -6.00 D at the spectacle plane, with a maximum MRSE ≤-12.00 D.
• Stable refraction for at least the last twelve months, as demonstrated by a change of less than 1.00 D of the spherical equivalent during the twelve months prior to the baseline examination of the eye to be treated, documented by previous clinical records.
• Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination.
• Hard contact lens wearers must have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 D.
• Visual acuity correctable to at least 20/40 in both eyes.
• UCVA of 20/40 or worse in the operative eye.
• At least 18 years of age.
• Operative eye must be targeted for emmetropia.
• Have a normal corneal topography.
• Willing and able to return for scheduled follow up examinations for twelve months after surgery.
• Sign and be given a copy of the written Informed Consent form.

Exclusion Criteria

• History of anterior segment pathology, including cataracts (in the operative eye).
• Clinically significant dry eye syndrome unresolved by treatment.
• Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars within the ablation zone or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease.
• Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect).
• An ablation deeper than 250 microns from the corneal endothelium.
• Irregular or unstable (distorted/not clear) corneal mires on central keratometry readings.
• Blind in the fellow eye.
• Undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes.
• History of ocular Herpes zoster or Herpes simplex keratitis.
• History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP >21 mm Hg.
• Must not have diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome.
• Must not be immunocompromised or use chronic systemic corticosteroid or other immunosuppressive therapy.
• Patients must not be pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
• Patients must not have a known sensitivity to planned study medications.
• Patients must not be participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
• For Fellow (Second) Eyes in Simultaneous Bilateral Treatment Procedures
• 1. Flap complications during the first eye's surgery such as a free cap, partial flap, thin flap, or irregular flap.
• 2. Epithelial defect exceeding 2 mm x 2 mm in dimension, or clinically significant debris in the interface between the flap and underlying stroma for the first eye.
• 3. Severe blepharospasm in the first eye that may have prevented or impeded the completion of the keratectomy and/or the laser ablation procedure.
• 4. Poor subject cooperation with instructions for the first eye's surgery and/or poor subject fixation on the laser fixation target.
• 5. Aborted LASIK procedure in the first eye or PRK was performed in the first eye because LASIK was not possible.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carl Zeiss Meditec, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Doane, MD

Role: PRINCIPAL_INVESTIGATOR

Discover Vision Centers

Richard Hoffman, MD

Role: PRINCIPAL_INVESTIGATOR

Fine, Hoffman, and Packer LLC

Howard Fine, MD

Role: PRINCIPAL_INVESTIGATOR

Fine, Hoffman, and Packer LLC

Mark Packer, MD

Role: PRINCIPAL_INVESTIGATOR

FIne, Hoffman, and Packer LLC

David Tanzer, MD

Role: PRINCIPAL_INVESTIGATOR

US Navy Refractive Surgery Center, San Diego, CA

John Vukich, MD

Role: PRINCIPAL_INVESTIGATOR

Davis Duehr Dean Eye Clinic

Jon Dishler, MD

Role: PRINCIPAL_INVESTIGATOR

Dishler Laser Institute

Locations

US Navy Refractive Surgery Center

San Diego, California, United States

Dishler Laser Institute

Greenwood Village, Colorado, United States

Discover Vision Centers

Kansas City, Missouri, United States

Fine, Hoffman, and Packer

Eugene, Oregon, United States

Davis Duehr Dean Eye Clinic

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

MEL 80-2006-1

Identifier Type: -

Identifier Source: org_study_id