NCT00762541

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

A Prospective Multicenter Trial To Evaluate The Safety And Effectiveness Of The MEL 80 Excimer Laser Using LASIK (Laser In Situ Keratomileusis) For The Correction Of > -7.00 D to -12.00 D Of Myopia With Up To -6.00 D Of Astigmatism, and Maximum MRSE of ≤ -12.00 D

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Carl Zeiss Meditec, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

LASIK has become one of the most common refractive eye procedures performed in the country. Currently the MEL 80 Excimer Laser System is approved for the elimination of myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a maximum MRSE of -7.00 D. The goal of this study is to assess the safety and effectiveness information on the treatment of moderate to high magnitudes of myopia.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	MEL 80 Treatment of High Myopia	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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2009-07-01
• First posted: 2008-09-30
• Last updated: 2018-07-19

Locations

5 sites across 1 country: United States