Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism
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|ClinicalTrials.gov Identifier: NCT01628146|
Recruitment Status : Unknown
Verified May 2015 by Technolas Perfect Vision GmbH.
Recruitment status was: Active, not recruiting
First Posted : June 26, 2012
Last Update Posted : May 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hyperopic Presbyopia||Device: SUPRACOR LASIK treatment||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PHASE IV STUDY # 1162. Prospective Investigation of SUPRACOR Visual Outcomes of Presbyopic Hyperopic Patients With and Without Astigmatism|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||October 2015|
Experimental: SUPRACOR LASIK treatment
SUPRACOR LASIK treatment
Device: SUPRACOR LASIK treatment
The SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction.
Other Name: LASIK
- High contrast intermediate visual acuity [ Time Frame: The study endpoints will be calculated for the 6-Month follow-up examination. ]The percentage of treated patients with a binocular uncorrected high contrast intermediate VA of 20/32 (0.4) or better. This percentage should be equal or greater than 60%.
- Contrast sensitivity [ Time Frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month. ]For all treated patients the mean value of the binocular photopic contrast sensitivity (log) for the various spatial frequencies should not decrease more than 0.30.
- Patient satisfaction [ Time Frame: The study endpoints will be calculated for the 3-Month and 6-Month follow-up examination. The defined study endpoints should be fulfilled at least for the final examination at 6-Month. ]The percentage of satisfied patient post SUPRACOR treatment. This percentage should be equal or greater than 75%.
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): NCT01628146
|Mater Private Hospital, Eye Laser Department|
|Dublin 7, Ireland|
|Principal Investigator:||Michael O'Keefe, MB, BAO, BcH||Mater Private Hospital, Dublin|