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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762281
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : August 13, 2012
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperopia Device: MEL 80 Hyperopic LASIK Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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. [ Time Frame: Point of stability ]
  2. 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. [ Time Frame: Point of stability ]
  3. 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. [ Time Frame: Point of stability ]
  4. 75% of eyes undergoing astigmatic treatment should be within ± 1.00 D of the attempted astigmatism correction by the point of stability. [ Time Frame: Point of stability ]
  5. 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. [ Time Frame: Point of stability ]
  6. Loss of more than 2 lines of BSCVA should occur in less than 5.0% of eyes. [ Time Frame: Point of stability ]
  7. 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. [ Time Frame: Point of stability ]
  8. Incidence of Adverse Events to occur in less 1% of eyes [ Time Frame: Postoperative visits ]

Secondary Outcome Measures :
  1. Subject Satisfaction: As measured by a subjective questionnaire, and will be considered as a secondary efficacy variable. [ Time Frame: Postoperative visits 3, 6, 9, 12, 18 and 24 months ]
  2. Incidence of Complications [ Time Frame: Postoperative visits ]
  3. Patient Symptoms: As measured by a subjective questionnaire, will be considered as a secondary safety variable. [ Time Frame: Preoperative and Postoperative visits 3, 6, 9, 12, 18 and 24 months ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762281


Locations
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United States, California
US Navy Refractive Surgery Center
San Diego, California, United States, 92106
United States, Colorado
Dishler Laser Institute
Greenwood Village, Colorado, United States, 80111
United States, Missouri
Discover Vision Centers
Kansas City, Missouri, United States, 64055
United States, Oregon
Fine, Hoffman, and Packer
Eugene, Oregon, United States, 97401
United States, Texas
Texan Eye Care
Austin, Texas, United States, 78746
United States, Wisconsin
Davis Duehr Dean Eye Clinic
Madison, Wisconsin, United States, 53717
Sponsors and Collaborators
Carl Zeiss Meditec, Inc.
Investigators
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Principal Investigator: Steven Dell, MD Texan Eye Care
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: Steve Schallhorn, 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
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Responsible Party: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT00762281    
Other Study ID Numbers: MEL 80-2004-2
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: August 13, 2012
Last Verified: August 2012
Keywords provided by Carl Zeiss Meditec, Inc.:
Hyperopia
Laser In Situ Keratomileusis
Laser Therapy
Laser Corneal Surgery
Refractive Surgical Procedures
Ophthalmologic Surgical Procedure
Operative Surgical Procedures
Therapeutics
Additional relevant MeSH terms:
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Hyperopia
Refractive Errors
Eye Diseases