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

• ClinicalTrials.gov Identifier: NCT01387360
• Recruitment Status: Completed
• First Posted: July 4, 2011
• Last Update Posted: May 20, 2015
• Sponsor: Technolas Perfect Vision GmbH
• 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• 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

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. doi: 10.3928/1081597X-20090512-05.

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. doi: 10.3928/1081597X-20080501-07.

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. doi: 10.3928/1081597X-20080901-03.

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.

• Responsible Party: Technolas Perfect Vision GmbH
• ClinicalTrials.gov Identifier: NCT01387360
• Other Study ID Numbers: 1107
• First Posted: July 4, 2011
• 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