Clinical trial NCT01404884: SUPRACOR for Myopia and Myopic Astigmatism
Official title: A Prospective Study To Evaluate The Safety And Effectiveness Of The SUPRACOR Presbyopic Treatment Algorithm For Myopia And Myopic Astigmatism Using LASIK
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Myopia
Myopic Astigmatism
Presbyopia
Keywords: myopia
astigmatism
presbyopia
SUPRACOR
multifocal
Lead sponsor: Technolas Perfect Vision GmbH
Sponsor class: INDUSTRY
First posted: 2011-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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).

Eligibility criteria: Inclusion Criteria:

* 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 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).
* 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

Primary outcomes:
measure: The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better
timeFrame: 3 Months
Secondary outcomes:
measure: The percentage of treated eyes within +/- 1.00D of target refraction
timeFrame: 3 Months
measure: The percentage of treated eyes within +/- 0.50D of target refraction
timeFrame: 3 Months
measure: The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better
timeFrame: 3 Months
measure: Stability analysis: change of <1D MRSE between two consecutive post-op visits
timeFrame: 3 Months
measure: Loss of more than 2 lines in BCVA for distance vision
timeFrame: 3 Months
measure: The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D
timeFrame: 3 Months
measure: Cumulative incidence of AEs
timeFrame: 3 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Instituto Oftalmologico Castanera
Study officials:
affiliation: Instituto Oftalmologico Castanera
name: Jorge Castanera, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Ortueta D. Is peripheral presbyLASIK a center-distance technique? J Refract Surg. 2008 Jun;24(6):561; author reply 562. doi: 10.3928/1081597X-20080601-01. No abstract available.
citation: Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alio JL. Correction of presbyopia in hyperopia with a center-distance, paracentral-near technique using the Technolas 217z platform. J Refract Surg. 2008 May;24(5):494-500. doi: 10.3928/1081597X-20080501-07.
citation: Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. doi: 10.3928/1081597X-20090512-05.
citation: Alio JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. doi: 10.1097/icu.0b013e32832a7ded.
citation: Pinelli R. More on peripheral PresbyLASIK as a center-distance technique. J Refract Surg. 2008 Sep;24(7):665. doi: 10.3928/1081597X-20080901-04. No abstract available.
citation: Ortiz D, Alio JL, Illueca C, Mas D, Sala E, Perez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. doi: 10.3928/1081-597X-20070101-07.