Clinical Trial: Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Technolas Perfect Vision GmbH

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Technolas Perfect Vision GmbH

Dates:
Date Received: June 28, 2011
Date Started: June 2011
Date Completion:
Last Updated: May 19, 2015
Last Verified: May 2015