SUPRACOR for Myopia and Myopic Astigmatism

Myopia Clinical Trial

— SUPRACOR  

Official title:

A Prospective Study To Evaluate The Safety And Effectiveness Of The SUPRACOR Presbyopic Treatment Algorithm For Myopia And Myopic Astigmatism Using LASIK

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01404884
• Other study ID #: 1105
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 27, 2011
• Last updated: May 19, 2015
• Start date: June 2011
• Est. completion date: April 2016

Study information

• Verified date: May 2015
• Source: Technolas Perfect Vision GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Myopic Astigmatism
• Presbyopia

Intervention

Procedure:
• SUPRACOR
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.

Locations

Country	Name	City	State
Spain	Instituto Oftalmologico Castanera	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Alió JL, Amparo F, Ortiz D, Moreno L. Corneal multifocality with excimer laser for presbyopia correction. Curr Opin Ophthalmol. 2009 Jul;20(4):264-71. Review. — View Citation

de Ortueta D. Is peripheral presbyLASIK a center-distance technique? J Refract Surg. 2008 Jun;24(6):561; author reply 562. — View Citation

Epstein RL, Gurgos MA. Presbyopia treatment by monocular peripheral presbyLASIK. J Refract Surg. 2009 Jun;25(6):516-23. — View Citation

Ortiz D, Alió JL, Illueca C, Mas D, Sala E, Pérez J, Espinosa J. Optical analysis of presbyLASIK treatment by a light propagation algorithm. J Refract Surg. 2007 Jan;23(1):39-44. — View Citation

Pinelli R, Ortiz D, Simonetto A, Bacchi C, Sala E, Alió 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. — View Citation

Pinelli R. More on peripheral PresbyLASIK as a center-distance technique. J Refract Surg. 2008 Sep;24(7):665. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better		3 Months	No
Secondary	The percentage of treated eyes within +/- 1.00D of target refraction		3 Months	No
Secondary	The percentage of treated eyes within +/- 0.50D of target refraction		3 Months	No
Secondary	The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better		3 Months	No
Secondary	Stability analysis: change of <1D MRSE between two consecutive post-op visits		3 Months	No
Secondary	Loss of more than 2 lines in BCVA for distance vision		3 Months	Yes
Secondary	The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D		3 Months	No
Secondary	Cumulative incidence of AEs		3 Months	Yes