SUPRACOR: Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

Sponsor

Technolas Perfect Vision GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01387360

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia Hyperopia Presbyopia	Device: Supracor	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supracor Study arm will consist of patients who have undergone previous cataract surgery with implantation of a monofocal IOL. The Supracor procedure will be performed on the non-dominant pseudophakic eye of these patients.	Device: Supracor The presbyopic treatment consists of a standard treatment for distance vision and the procedure known as SUPRACOR addition to correct near vision. The SUPRACOR addition provides a multifocal ablation with a central near addition with an aberration controlled transition zone towards the periphery, thereby allowing good focus over a range of object distances. Other Names: PresbyLASIK Multifocal Ablation

Arm

Intervention/Treatment

Experimental: Supracor

Study arm will consist of patients who have undergone previous cataract surgery with implantation of a monofocal IOL. The Supracor procedure will be performed on the non-dominant pseudophakic eye of these patients.

Device: Supracor

The presbyopic treatment consists of a standard treatment for distance vision and the procedure known as SUPRACOR addition to correct near vision. The SUPRACOR addition provides a multifocal ablation with a central near addition with an aberration controlled transition zone towards the periphery, thereby allowing good focus over a range of object distances.

Other Names:

PresbyLASIK

Multifocal Ablation

Outcome Measures

Primary Outcome Measures

The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better [6M]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).