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SUPRACOR for Myopia and Myopic Astigmatism (SUPRACOR)

Primary Purpose

Myopia, Myopic Astigmatism, Presbyopia

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

SUPRACOR

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia, astigmatism, presbyopia, SUPRACOR, multifocal

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Instituto Oftalmologico Castanera

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SUPRACOR

Arm Description

Treatment arm consisting of patients with history of myopia or myopic astigmatism who are also diagnosed with presbyopia.

Outcomes

Primary Outcome Measures

The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better

Secondary Outcome Measures

The percentage of treated eyes within +/- 1.00D of target refraction

The percentage of treated eyes within +/- 0.50D of target refraction

The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better

Stability analysis: change of <1D MRSE between two consecutive post-op visits

Loss of more than 2 lines in BCVA for distance vision

The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D

Cumulative incidence of AEs

Full Information

NCT ID

NCT01404884

First Posted

July 27, 2011

Last Updated

May 19, 2015

Sponsor

Technolas Perfect Vision GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01404884

Brief Title

SUPRACOR for Myopia and Myopic Astigmatism

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technolas Perfect Vision GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Myopic Astigmatism, Presbyopia

Keywords

myopia, astigmatism, presbyopia, SUPRACOR, multifocal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SUPRACOR

Arm Type

Experimental

Arm Description

Treatment arm consisting of patients with history of myopia or myopic astigmatism who are also diagnosed with presbyopia.

Intervention Type

Procedure

Intervention Name(s)

SUPRACOR

Other Intervention Name(s)

PresbyLASIK

Intervention Description

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.

Primary Outcome Measure Information:

Title

The percentage of treated eyes with a best corrected high contrast distance VA of 20/25 or better

Time Frame

3 Months

Secondary Outcome Measure Information:

Title

The percentage of treated eyes within +/- 1.00D of target refraction

Time Frame

3 Months

Title

The percentage of treated eyes within +/- 0.50D of target refraction

Time Frame

3 Months

Title

The percentage of treated eyes with an uncorrected high contrast near VA of 20/40 or better

Time Frame

3 Months

Title

Stability analysis: change of <1D MRSE between two consecutive post-op visits

Time Frame

3 Months

Title

Loss of more than 2 lines in BCVA for distance vision

Time Frame

3 Months

Title

The percentage of treated eyes with an induced subjective manifest refraction cylinder not within +/- 2.00D

Time Frame

3 Months

Title

Cumulative incidence of AEs

Time Frame

3 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Castanera, M.D.

Organizational Affiliation

Instituto Oftalmologico Castanera

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto Oftalmologico Castanera

City

Barcelona

ZIP/Postal Code

08006

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

18581778

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.

Results Reference

background

PubMed Identifier

18494342

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.

Results Reference

background

PubMed Identifier

19603619

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.

Results Reference

result

PubMed Identifier

19537363

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.

Results Reference

result

PubMed Identifier

18811107

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.

Results Reference

result

PubMed Identifier

17269242

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.

Results Reference

result

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SUPRACOR for Myopia and Myopic Astigmatism

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