Safety and Effectiveness Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Hyperopia

A Prospective, Randomized, Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of ≤ +6.0 D Of Hyperopia With Or Without Astigmatism Of +0.50 D To +3.50 D And MRSE ≤ +6.50 D

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

Study Overview

• Status: Completed
• Conditions: Hyperopia
• Intervention / Treatment: Device: MEL 80 Hyperopic LASIK Treatment

Detailed Description

LASIK has become one of the most common refractive eye procedures performed in the country. In the hyperopia procedure, a steepening occurs on the corneal surface, rather than the flattening procedure (myopic treatment). The surgeon will produce a standard keratomileusis flap using a microkeratome, exposing the corneal stroma. Recontouring under the flap is then accomplished by the removal of tissue from the stroma with the laser. This recontouring results in an altering of effective lens power of the central cornea, measured in diopters (D). The MEL 80 Excimer Laser System will be evaluated for its ability to create accurate and stable hyperopic refractive correction results.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92106
      • US Navy Refractive Surgery Center
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Dishler Laser Institute
  • Missouri
    • Kansas City, Missouri, United States, 64055
      • Discover Vision Centers
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Fine, Hoffman, and Packer
  • Texas
    • Austin, Texas, United States, 78746
      • Texan Eye Care
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • Davis Duehr Dean Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Naturally occurring hyperopia up to +6.0 D, with or without astigmatism of +0.50 D to +3.50 D at the spectacle plane, and MRSE ≤ +6.50 D;
• Have ≤ 0.75 D of latent hyperopia as determined by the difference between the preoperative MRSE and CRSE;
• A stable refraction for at least the last 12 months as documented by previous clinical records, i.e., the spherical and cylindrical portions of the manifest refraction have not progressed at a rate of more than 0.50 D during the year prior to the baseline examination in the eye to be treated;
• 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;
• Operative eye must be targeted for emmetropia;
• At least 21 years of age;
• Willing and able to return for scheduled follow up examinations for 24 months after surgery;
• Sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

• A history of anterior segment pathology, including cataracts (in the operative eye);
• Severe 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 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 excimer laser surgery for either refractive or therapeutic purposes;
• A history of ocular Herpes zoster or Herpes simplex keratitis;
• A history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP >21 mm Hg;
• Diabetes, diagnosed autoimmune disease, connective tissue disease, or clinically significant atopic syndrome;
• Immunocompromised or use chronic systemic corticosteroid or other immunosuppressive therapy;
• Pregnant, lactating, or be of childbearing potential and not practicing a medically approved method of birth control;
• A known sensitivity to planned study medications;
• Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
• At risk for angle closure or for developing strabismus postoperatively.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment of Hyperopic LASIK; Treatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D.	Device: MEL 80 Hyperopic LASIK Treatment; Treatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
At the point of stability, a minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.	Point of stability
A minimum of 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
A minimum of 85% of eyes targeted for emmetropia should have an uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established.	Point of stability
75% of eyes undergoing astigmatic treatment should be within ± 1.00 D of the attempted astigmatism correction by the point of stability.	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 1.0% 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 5.0% 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 1% of eyes	Postoperative visits

Secondary Outcome Measures

Outcome Measure	Time Frame
Subject Satisfaction: As measured by a subjective questionnaire, and will be considered as a secondary efficacy variable.	Postoperative visits 3, 6, 9, 12, 18 and 24 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, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec, Inc.
• Investigators: Principal Investigator: 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: Steven Dell, MD, Texan Eye Care; Principal Investigator: Steve Schallhorn, MD, US Navy Refractive Surgery Center, San Diego, CA

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): August 13, 2012
• Last Update Submitted That Met QC Criteria: August 9, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Therapeutics; Hyperopia; Laser Therapy; Laser In Situ Keratomileusis; Laser Corneal Surgery; Refractive Surgical Procedures; Ophthalmologic Surgical Procedure; Operative Surgical Procedures
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: MEL 80-2004-2