Status:
UNKNOWN
SUPRACOR for Myopia and Myopic Astigmatism
Lead Sponsor:
Technolas Perfect Vision GmbH
Conditions:
Myopia
Myopic Astigmatism
Eligibility:
All Genders
45-85 years
Phase:
PHASE3
Brief Summary
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 hu...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- Subjects must be at least 45 years old and not older than 85 years
- 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 3 months after surgery.
- Subjects must have up to -7.0 diopters (D) of absolute spherical myopia (not spherical equivalent), with up to -4.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent and must be no more than -9.0 D.
- Subjects must have presbyopia as determined by an age-related need for optical aid(\> +1.50 D) for reading with their best distance correction.
- Subjects who have be screened successfully for acceptance of the SUPRACOR simulation
- Subjects who are contact lens wearers must have gas permeable (GP) lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 1 week prior to the preoperative evaluation in the eye to be treated.
- High contrast, manifest, best spectacle-corrected logMAR distance visual acuity (VA) must be correctable to at least 0.0 (20/20 or 6/6) in both eyes.
Exclusion
- 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).
- Subjects with anterior segment pathology, including dry eye syndrome and cataracts which in the Investigator's opinion, would interfere with best spectacle-corrected VA (BSCVA) or a successful treatment.
- Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of excimer laser surgery for either refractive or therapeutic purposes. Previous LASIK treatment and standard cataract surgery is not an exclusion criteria
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01404884
Start Date
June 1 2011
End Date
April 1 2016
Last Update
May 20 2015
Active Locations (1)
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1
Instituto Oftalmologico Castanera
Barcelona, Spain, 08006