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

NCT00762541 | Completed DMC

• 1 other identifier: MEL 80-2006-1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 5

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.

Conditions

Myopia

Keywords

Myopia; Laser In Situ Keratomileusis; Laser Therapy; Laser Corneal Surgery; Refractive Surgical Procedures; Ophthalmologic Surgical Procedure; Operative Surgical Procedures; Therapeutics

Outcome Measures

Primary Outcomes (7)

• At the point of stability, for myopes > 7 D spherical equivalent (SE), a minimum of 30% should have an achieved refraction within ± 0.50 D of the intended outcome, and 60% should have an achieved refraction within ± 1.00 D of the intended outcome.

  Point of stability

• For myopes > 7 D spherical equivalent (SE), a minimum of 75% of eyes should have an uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established.

  Point of stability

• 95% of eyes should have a change of < 1.00 D in manifest refraction spherical equivalent (MRSE) between 2 refractions performed at least 3 months apart, and the mean rate of MRSE change per month should be < 0.04 D.

  Point of stability

• Distance BSCVA of worse than 20/40 at the postoperative interval at which stability has been established should occur in less than 1% of eyes that had a BSCVA of 20/20 or better before surgery.

  Point of stability

• Loss of more than 2 lines of BSCVA should occur in less than 5% of eyes

  Point of stability

• Less than 5% of eyes treated for sphere only should have a magnitude of postoperative manifest refractive astigmatism that varies from baseline cylinder by greater than 2.00 D at the postoperative interval at which stability has been established.

  Point of stability

• Incidence of Adverse Events to occur in less than 1% of eyes

  Postopertive visits

Secondary Outcomes (3)

• Subject Satisfaction: As measured by a subjective questionnaire, and will be considered as a secondary efficacy variable.

  Postoperative visits 3, 6, 9 and 12 months

• Incidence of Complications

  Postoperative visits

• Patient Symptoms: As measured by a subjective questionnaire, will be considered as a secondary safety variable

  Preoperative and Postoperative visits 3, 6, 9 and 12 months

Interventions

MEL 80 Treatment of High Myopia DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (5)

US Navy Refractive Surgery Center

San Diego, California, 92106, United States

Location

Dishler Laser Institute

Greenwood Village, Colorado, 80111, United States

Location

Discover Vision Centers

Kansas City, Missouri, 64055, United States

Location

Fine, Hoffman, and Packer

Eugene, Oregon, 97401, United States

Location

Davis Duehr Dean Eye Clinic

Madison, Wisconsin, 53717, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• John Doane, MD

  Discover Vision Centers

  PRINCIPAL INVESTIGATOR

• Richard Hoffman, MD

  Fine, Hoffman, and Packer LLC

  PRINCIPAL INVESTIGATOR

• Howard Fine, MD

  Fine, Hoffman, and Packer LLC

  PRINCIPAL INVESTIGATOR

• Mark Packer, MD

  FIne, Hoffman, and Packer LLC

  PRINCIPAL INVESTIGATOR

• David Tanzer, MD

  US Navy Refractive Surgery Center, San Diego, CA

  PRINCIPAL INVESTIGATOR

• John Vukich, MD

  Davis Duehr Dean Eye Clinic

  PRINCIPAL INVESTIGATOR

• Jon Dishler, MD

  Dishler Laser Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: October 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

US (5)