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

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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Myopia; Hyperopia
• Intervention / Treatment: Device: Supracor

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Philippines
  • Manila
    • Makati, Manila, Philippines
      • Asian Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better	6M

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Technolas Perfect Vision GmbH
• Investigators: Study Director: Robert Ang, M.D., Asian Eye Institute

Publications and helpful links

General Publications

• de Ortueta D. Is peripheral presbyLASIK a center-distance technique? J Refract Surg. 2008 Jun;24(6):561; author reply 562. doi: 10.3928/1081597X-20080601-01. No abstract available.
• Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. doi: 10.3928/1081597X-20090512-05.
• Alio JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. doi: 10.1097/icu.0b013e32832a7ded.
• Ortiz D, Alio JL, Illueca C, Mas D, Sala E, Perez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. doi: 10.3928/1081-597X-20070101-07.
• Pinelli R. More on peripheral PresbyLASIK as a center-distance technique. J Refract Surg. 2008 Sep;24(7):665. doi: 10.3928/1081597X-20080901-04. No abstract available.
• Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alio JL. Correction of presbyopia in hyperopia with a center-distance, paracentral-near technique using the Technolas 217z platform. J Refract Surg. 2008 May;24(5):494-500. doi: 10.3928/1081597X-20080501-07.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2015
• Last Update Submitted That Met QC Criteria: May 19, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Hyperopia; Myopia; LASIK; Presbyopia; Pseudophakia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Myopia; Hyperopia
• Other Study ID Numbers: 1107