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Completed

NCT Number: NCT01387360

Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes

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.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asian Eye Institute

Makati, Manila, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Supracor

Device

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

Primary outcomes

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

    Time frame: 6M

Secondary outcomes

  1. The percentage of treated eyes within +/- 1.00D of target refraction

    Time frame: 6M

  2. The percentage of treated eyes within +/- 0.50D of target refraction

    Time frame: 6M

  3. The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better

    Time frame: 6M

  4. Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits

    Time frame: 6M

  5. Preservation of VA: Loss of more than 2 lines in BCVA for distance vision

    Time frame: 6M

  6. The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better

    Time frame: 6M

  7. The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D

    Time frame: 6M

  8. Cumulative incidence of AEs

    Time frame: 6M

  9. Cumulative incidence subjective symptoms

    Time frame: 6M

Sponsors and collaborators

Lead sponsor

Technolas Perfect Vision GmbH

Industry

Registry information

Official study title

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

Acronym: SUPRACOR

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 4, 2011
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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