NCT01628146

Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism

PHASE IV STUDY # 1162. Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This phase IV study is an open, prospective, single-center, single-surgeon bilateral eye study to investigate the bilateral uncorrected intermediate visual acuity of presbyopic hyperopic patients, who have been treated with Presbyopia Algorithm SUPRACOR.

Detailed description

The developed software algorithm SUPRACOR uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for hyperopic cases. In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision. Excimer Laser Technolas® 217z100P, High Speed Session Management Software (KERACOR V5.0) and ZYOPTIX Cards as well as all the diagnostic devices that are used in the #1162 study are CE certified and are used for their standard purpose. This study will be conducted at Mater Private Hospital (Eye Laser Department) by Professor Michael O'Keefe who would recruit up to 40 subjects according to the inclusion/exclusion criteria.

Conditions

• Hyperopic Presbyopia

Interventions

Type	Name	Description
DEVICE	SUPRACOR LASIK treatment	The SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction.

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-07-01
• Completion: 2015-10-01
• First posted: 2012-06-26
• Last updated: 2015-05-20

Locations

1 site across 1 country: Ireland