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

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.

ClinicalTrials.gov Identifier: NCT01387360

Recruitment Status : Completed

First Posted : July 4, 2011

Last Update Posted : May 20, 2015

Sponsor:

Information provided by (Responsible Party):

Technolas Perfect Vision GmbH

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 (Clinical Trial)
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 :	June 2011
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 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 [ 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	45 Years to 85 Years (Adult, Older Adult)
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

Publications of Results:

Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23.

Alió JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. Review.

Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alió 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.

Ortiz D, Alió JL, Illueca C, Mas D, Sala E, Pérez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44.

Other Publications:

Pinelli R. More on peripheral PresbyLASIK as a center-distance technique. J Refract Surg. 2008 Sep;24(7):665.

de Ortueta D. Is peripheral presbyLASIK a center-distance technique? J Refract Surg. 2008 Jun;24(6):561; author reply 562.


Responsible Party:	Technolas Perfect Vision GmbH
ClinicalTrials.gov Identifier:	NCT01387360 History of Changes
Other Study ID Numbers:	1107
First Posted:	July 4, 2011 Key Record Dates
Last Update Posted:	May 20, 2015
Last Verified:	May 2015

Keywords provided by Technolas Perfect Vision GmbH:


Myopia Hyperopia Presbyopia Pseudophakia LASIK

Additional relevant MeSH terms:


Myopia Presbyopia Hyperopia Refractive Errors Eye Diseases

To Top