A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and Presbyopia

Technolas Perfect Vision GmbH0 sites97 target enrollmentDecember 2014

ConditionsMyopia Hyperopia Presbyopia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Myopia
Sponsor: Technolas Perfect Vision GmbH
Enrollment: 97
Primary Endpoint: For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and Presbyopia

Detailed Description

This clinical study has been planned to evaluate the safety and effectiveness of the excimer laser treatment algorithms Proscan, Zyoptix and Supracor of the 500 Hz laser system for ametropia and/or presbyopia when performed on the cornea of virgin eyes.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

May 2017

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Technolas Perfect Vision GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects have to be at least 18 years of age.
•Subjects have to be able to read, understand, and sign a statement of Informed Consent (be given a copy of the signed Informed Consent Form (ICF).
•Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 respectively 12 months after surgery.
•For Proscan and Zyoptix Treatments the myopic subjects require a sphere between -0.5 D up to a maximum sphere of -10.0 D. If the patient has a refractive astigmatism to be treated, this must be between -0.5 D up to -4.0 D (not corneal astigmatism) as expressed in spectacle minus cylinder form (by manifest subjective refraction). Overall the SE for myopes must be no more than -12.0 D.
•The Hyperopic subjects require a sphere between +0.5 D up to a maximum sphere of +4.0 D. If the patient has a refractive astigmatism to be treated, this must be between +0.5 D up to +4.0 D (not corneal astigmatism) as expressed in spectacle plus cylinder form (by manifest subjective refraction). Overall the SE for hyperopes must be no more than +6.0 D.
•Subjects who are contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 1 week prior to the pre-operative evaluation in the eye to be treated.
•Corneal topography should be qualified.
•Subjects who are contact lens wearers must have two (2) central keratometry readings and two (2) manifest subjective refractions taken pre-operatively at least one week apart. The refraction values must not differ by more than 0.50 D as defined by manifest refraction spherical equivalent (MRSE). The keratometry values must not differ from the previous values by more than 0.50 D in either meridian.
•High contrast, manifest, best spectacle-corrected distance visual acuity correctable binocular to at least 1.0 (Snellen 20/20 or 6/6) and monocular to at least 0.8 (Snel-len 20/25 or 6/7.5). In case of a monocular surgery the eye which should not be treated must have a best corrected distance visual acuity of at least 0.8 (Snellen 20/25 or 6/7.5).
•For treatments with the SUPRACOR presbyopic algorithm, subjects have to be at least 45 years old and no more than 85 years.

Exclusion Criteria

•Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
•Hyperopic eyes for which the baseline manifest subjective refraction exhibits a difference of greater than ± 0.75 D in sphere power, or a difference of greater than ± 0.50 D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than ±0.75 D, the difference in cylinder axis would not be taken into consideration.
•Any subject who is going to be co-managed by an ophthalmologist or optometrist who were not approved as a Technolas Perfect Vision Investigator.
•Subjects with anterior segment pathology, including dry eye syndrome and cataracts, which in the Investigator's opinion would interfere with best spectacle-corrected visual acuity or a successful treatment.
•Subjects with evidence of retinal vascular disease.
•Subjects with any residual, recurrent, or active ocular disease, or corneal abnormality that in the Investigator's opinion would interfere with BSCVA or a successful treatment.
•Subjects with signs of keratoconus.
•Subjects with unstable central keratometry readings with irregular mires.
•Subjects who had previous intraocular or corneal surgery of any kind, including any type of Excimer laser surgery for either refractive or therapeutic purposes.
•Subjects who have a history of Herpes simplex or Herpes zoster keratitis.

Outcomes

Primary Outcomes

For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better

Time Frame: Myopia: 6 months, Hyperopia 12 months