Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Mixed Astigmatism

NCT00761826 | Completed DMC

• 1 other identifier: MEL 80-2006-2
• Study Type: interventional
• Target: 126
• 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 mixed astigmatism up to 6.0 D, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.

Conditions

Mixed Astigmatism

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 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

• 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.

  Postoperative visits

• Incidence of adverse events to occur in less than 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 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 Mixed Astigmatism Treatment DEVICE

Treatment of Naturally Occuring Mixed Astigmatic corrections up to 6.0 D.

Eligibility Criteria

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

You may qualify if:

• Naturally occurring mixed astigmatism when the magnitude of cylinder (up to 6.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs, at the spectacle plane;
• Have a stable refraction for at least the past twelve months, as demonstrated by a change of less than or equal to 0.50 D preoperative spherical equivalent shift over twelve months prior to surgery;
• 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
• Have visual acuity correctable to at least 20/40 in both eyes
• Have no more than 0.75 D of latent hyperopia as determined by the difference between the preoperative manifest refractive spherical equivalent (MRSE) and cycloplegic refractive spherical equivalent (CRSE);
• Be at least 18 years of age
• Corneal topography should be normal;
• The operative eye must be targeted for emmetropia;
• Be willing and able to return for scheduled follow-up examinations for twelve months after surgery;
• and provide written informed consent.

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 keratoconus (or keratoconus suspect);
• Required ablation is 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;
• 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;
• Diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
• Immunocompromised patients, or use of chronic systemic corticosteroid or other immunosuppressive therapy;
• Pregnant, lactating, or child-bearing potential and not practicing a medically approved method of birth control;
• Sensitivity to planned study medications;
• Simultaneous participation in other ophthalmic drug or device clinical trial.

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

Astigmatism

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: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: July 19, 2018

Record last verified: 2018-01

Locations

US (5)