SUPRACOR for Myopia and Myopic Astigmatism (SUPRACOR)
This clinical study has been planned to evaluate the safety and effectiveness of the SUPRACR presbyopic excimer laser treatment algorithm for myopic eyes developed for applying to the cornea of the human eye in a single center.
The developed software algorithm 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 aspheric LASIK treatment for myopic cases.
In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision.
The study design is applied as a single center unilateral eye safety and effectiveness study of the SUPRACOR presbyopic algorithm for myopia with a 3 months postoperative follow up.
|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 Myopia And Myopic Astigmatism Using LASIK|
- The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
- The percentage of treated eyes within +/- 1.00D of target refraction [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
- The percentage of treated eyes within +/- 0.50D of target refraction [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
- The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
- Stability analysis: change of <1D MRSE between two consecutive post-op visits [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
- Loss of more than 2 lines in BCVA for distance vision [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
- The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
- Cumulative incidence of AEs [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Treatment arm consisting of patients with history of myopia or myopic astigmatism who are also diagnosed with presbyopia.
The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision.
Other Name: PresbyLASIK
Presbyopia is an age-related progressive decrease in the ability to bring near objects to clear focus. It is attributed to changes in the accommodative apparatus in the visual system which includes the ciliary muscle and crystalline lens. Current Presbyopia management includes bifocal or multifocal corrections in spectacles or contact lenses that provide good focus over a range of object distances.
Current LASIK refractive surgery algorithms using Excimer laser are a safe, effective, and precise way to treat ametropia in eyes with regular corneas. The LASIK procedure uses a microkeratome to create a lamellar resection of the cornea at an intended depth ranging from 90 to 160 microns. The microkeratome is designed to maintain a "hinge" of tissue so that a flap of corneal epithelium and superficial stroma can be lifted to expose deeper stromal tissue while remaining attached to the cornea. The ablative energy of the excimer laser is then applied directly on the exposed corneal stroma to remove the required amount of tissue for a given refractive error. The amount of corneal tissue to be removed is determined by the magnitude of refractive correction and treatment area (optic zone). Once the laser ablation is completed, the flap is repositioned over the residual stromal bed.
The presbyopic treatment consists of a standard aspheric treatment for distance vision and the so called 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. This approach showed good near visual performance in hyperopic eyes (see also section 2.1).
The SUPRACOR presbyopic treatment algorithm subject to this study has been specifically developed to prospectively generate a treatment file for the Technolas 217z100 laser that will provide Presbyopia correction among eyes with primary myopia or myopic astigmatism (distance correction).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404884
|Instituto Oftalmologico Castanera|
|Barcelona, Spain, 08006|
|Principal Investigator:||Jorge Castanera, M.D.||Instituto Oftalmologico Castanera|