A Prospective Study to Evaluate the Safety and Effectiveness of the Supracor Presbyopic Treatment Algorithm for Pseudophakic Eyes Using Lasik

Technolas Perfect Vision GmbH1 site in 1 country33 target enrollmentJune 2011

ConditionsMyopia Hyperopia Presbyopia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Myopia
Sponsor: Technolas Perfect Vision GmbH
Enrollment: 33
Locations: 1
Primary Endpoint: The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical study has been planned to determine the effectiveness of a special laser treatment intended to correct both near and distance vision in patients who have undergone previous cataract surgery.

Detailed Description

This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACOR presbyopic excimer laser treatment algorithm for near myopic and near hyperopic indications, with or without astigmatism, when performed on the cornea of pseudophakic eyes implanted with a monofocal IOL.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

October 2014

Last Updated

10 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 must be at least 45 years old
•Subjects must read, understand, and sign an Informed Consent Form (ICF).
•Subjects must be willing and able to return for scheduled follow-up examinations through 6 months after surgery.
•Subjects must have undergone previous uncomplicated cataract surgery with monofocal IOL implant in the study eye at least 3 months prior to study enrollment.
•Subjects must have up to +/- 2.0 (D) of absolute spherical myopia or hyperopia (not spherical equivalent), with up to +/- 2.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent must be no more than +/- 2.0 D.
•Subjects who have be screened successfully for acceptance of the SUPRACOR simulation

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 corneal thickness below the flap postoperatively.
•Subjects for whom the preoperative assessment of the ocular topography indicates that one or both eyes are not suitable candidates for treatment based upon the suggested computer-simulated treatment plan (e.G. Keratoconus).

Outcomes

Primary Outcomes

The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better

Time Frame: 6M

Secondary Outcomes

The percentage of treated eyes within +/- 1.00D of target refraction(6M)
The percentage of treated eyes within +/- 0.50D of target refraction(6M)
The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better(6M)
Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits(6M)
Preservation of VA: Loss of more than 2 lines in BCVA for distance vision(6M)
The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better(6M)
The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D(6M)
Cumulative incidence of AEs(6M)
Cumulative incidence subjective symptoms(6M)