SUPRACOR for Myopia and Myopic Astigmatism

NCT01404884 | Unknown Phase 3

• 1 other identifier: 1105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Myopic Astigmatism; Presbyopia

Keywords

myopia; astigmatism; presbyopia; SUPRACOR; multifocal

Outcome Measures

Primary Outcomes (1)

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

  3 Months

Secondary Outcomes (7)

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

  3 Months

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

  3 Months

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

  3 Months

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

  3 Months

• Loss of more than 2 lines in BCVA for distance vision

  3 Months

Study Arms (1)

SUPRACOR

EXPERIMENTAL

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

Procedure: SUPRACOR

Interventions

SUPRACOR PROCEDURE

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.

Also known as: PresbyLASIK

SUPRACOR

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (1)

Instituto Oftalmologico Castanera

Barcelona, 08006, Spain

Location

Related Publications (6)

• 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.

  PMID: 18581778 BACKGROUND

• 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.

  PMID: 18494342 BACKGROUND

• 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.

  PMID: 19603619 RESULT

• 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.

  PMID: 19537363 RESULT

• 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.

  PMID: 18811107 RESULT

• 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.

  PMID: 17269242 RESULT

MeSH Terms

Conditions

Myopia; Astigmatism; Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Jorge Castanera, M.D.

  Instituto Oftalmologico Castanera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 28, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

ES (1)