Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic Eyes (SUPRACOR)
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ClinicalTrials.gov Identifier: NCT01387360 |
Recruitment Status :
Completed
First Posted : July 4, 2011
Last Update Posted : May 20, 2015
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Condition or disease | Intervention/treatment | Phase |
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Myopia Hyperopia Presbyopia | Device: Supracor | Phase 4 |
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 |

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

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Ages Eligible for Study: | 45 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
Philippines | |
Asian Eye Institute | |
Makati, Manila, Philippines |
Study Director: | Robert Ang, M.D. | Asian Eye Institute |
Other Publications:
Responsible Party: | Technolas Perfect Vision GmbH |
ClinicalTrials.gov Identifier: | NCT01387360 |
Other Study ID Numbers: |
1107 |
First Posted: | July 4, 2011 Key Record Dates |
Last Update Posted: | May 20, 2015 |
Last Verified: | May 2015 |
Myopia Hyperopia Presbyopia Pseudophakia LASIK |
Myopia Presbyopia Hyperopia Refractive Errors Eye Diseases |