Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cataract

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The percentage of treated eyes within +/- 1.00D of target refraction [ Time Frame: 6M ] [ Designated as safety issue: No ]
The percentage of treated eyes within +/- 0.50D of target refraction [ Time Frame: 6M ] [ Designated as safety issue: No ]
The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better [ Time Frame: 6M ] [ Designated as safety issue: No ]
Stability analysis: change of ≤ 1D MRSE between two consecutive post-op visits [ Time Frame: 6M ] [ Designated as safety issue: No ]
Preservation of VA: Loss of more than 2 lines in BCVA for distance vision [ Time Frame: 6M ] [ Designated as safety issue: Yes ]
The percentage of treated eyes with a best-distance corrected high contrast distance VA of 20/40 or better [ Time Frame: 6M ] [ Designated as safety issue: Yes ]
The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D [ Time Frame: 6M ] [ Designated as safety issue: Yes ]
Cumulative incidence of AEs [ Time Frame: 6M ] [ Designated as safety issue: Yes ]
Cumulative incidence subjective symptoms [ Time Frame: 6M ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	June 2011
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	January 2012 (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

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

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387360

Contacts

Contact: Shiela DeCastro	09167391862
Contact: Ferdinand Dollente	+6328982020 ext 510

Locations

Philippines
Asian Eye Institute	Recruiting
Makati, Manila, Philippines
Contact: Shiela DeCastro 09167391862
Contact: Ferdinand Dollente +6328982020 ext 510
Principal Investigator: Robert Ang, M.D.

Sponsors and Collaborators

Technolas Perfect Vision GmbH

Investigators

Study Director:

Robert Ang, M.D.

Asian Eye Institute

More Information

Publications:

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.

Pinelli R. More on peripheral PresbyLASIK as a center-distance technique. J Refract Surg. 2008 Sep;24(7):665. No abstract available.

de Ortueta D. Is peripheral presbyLASIK a center-distance technique? J Refract Surg. 2008 Jun;24(6):561; author reply 562. No abstract available.

Responsible Party:	Dr. Gerhard Youssefi, Vice President Research and Clinical Operations, Technolas Perfect Vision, GmbH
ClinicalTrials.gov Identifier:	NCT01387360 History of Changes
Other Study ID Numbers:	1107
Study First Received:	June 28, 2011
Last Updated:	June 30, 2011
Health Authority:	Philippines: Department of Health

Keywords provided by Technolas Perfect Vision GmbH:

Myopia
Hyperopia
Presbyopia
Pseudophakia
LASIK

Additional relevant MeSH terms:

Hyperopia
Myopia
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013

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