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

NCT00762281 | Completed DMC

• 1 other identifier: MEL 80-2004-2
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 6

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.

Conditions

Hyperopia

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 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

• 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

• 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 Outcomes (3)

• 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

Study Arms (1)

Treatment of Hyperopic LASIK

OTHER

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

Interventions

MEL 80 Hyperopic LASIK Treatment DEVICE

Treatment of Hyperopic corrections ≤ +6.0 D with or without Astigmatism of +0.50 to +3.50 D and MRSE ≤ +6.50 D.

Treatment of Hyperopic LASIK

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Carl Zeiss Meditec, Inc.: lead

Study Sites (6)

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

Texan Eye Care

Austin, Texas, 78746, United States

Location

Davis Duehr Dean Eye Clinic

Madison, Wisconsin, 53717, United States

Location

MeSH Terms

Conditions

Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• 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

  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: July 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2008
• Last Updated: August 13, 2012

Record last verified: 2012-08

Locations

US (6)