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Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes (SUPRACOR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01387360
First Posted: July 4, 2011
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technolas Perfect Vision GmbH
  Purpose
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 Intervention Phase
Myopia Hyperopia Presbyopia Device: Supracor Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Technolas Perfect Vision GmbH:

Primary Outcome Measures:
  • The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better [ Time Frame: 6M ]

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

Enrollment: 33
Study Start Date: June 2011
Study Completion Date: October 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387360


Locations
Philippines
Asian Eye Institute
Makati, Manila, Philippines
Sponsors and Collaborators
Technolas Perfect Vision GmbH
Investigators
Study Director: Robert Ang, M.D. Asian Eye Institute
  More Information
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