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Multicenter Evaluation of Safety and Effectiveness of Presbyopic LASIK for Hyperopes (PresbyLASIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00910403
Recruitment Status : Completed
First Posted : May 29, 2009
Last Update Posted : May 26, 2011
Information provided by:
Technolas Perfect Vision GmbH

Brief Summary:
The Presbyopia 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 hyperopia or hyperopic astigmatism (distance correction). The treatment algorithm provides a bilateral, multifocal ablation with a center near addition, thereby allowing good focus over a range of object distances.

Condition or disease Intervention/treatment Phase
Presbyopia Hyperopia Procedure: LASIK Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter, Study to Evaluate the Safety and Effectiveness of the Presbyopia Algorithm for Hyperopia and Hyperopic Astigmatism Using LASIK
Study Start Date : June 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Procedure: LASIK
    Excimer Laser Ablation using LASIK
    Other Name: PresbyLASIK

Primary Outcome Measures :
  1. Binocular uncorrected VA better than 20/40 [ Time Frame: 6 M ]

Secondary Outcome Measures :
  1. Percentage of eyes within +/- 1D from target refraction [ Time Frame: 6M ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must be at least 18 years old
  • Subjects must read, understand, and sign an Informed Consent Form (ICF).
  • Subjects must be willing and able to return for scheduled follow up visits.
  • Subjects must be willing to have both eyes treated during the same visit.
  • Subjects must have up to +4 diopters (D) of absolute spherical hyperopia (not spherical equivalent), with up to +2.5 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than +5.25 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 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. Contact lens wearers who wear their contact lenses for any amount of time between the preoperative baseline examination and the operative visit must not be treated.
  • Corneal topography should be normal.
  • Subjects who are contact lens wearers must have 2 central keratometry readings and 2 manifest subjective refractions taken preoperatively at least one week apart. The refraction values must not differ by more than 0.50D as defined by manifest refraction spherical equivalent (MRSE). The keratometry values must not differ from the previous values by more than 0.50D in either meridian.
  • High contrast, manifest, best spectacle-corrected logMAR distance visual acuity (VA) must be correctable to at least 0.1 (20/25 or 6/7.5) 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 posterior corneal thickness below the flap postoperatively.
  • Eyes for which the baseline manifest subjective refraction exhibits a difference of greater than 0.75D in sphere power, or a difference of greater than 0.50D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than 0.75D, the difference in cylinder axis will not be taken into consideration.
  • 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.
  • Any subject who is going to be co-managed by an ophthalmologist or optometrist who is not approved as a Technolas GmbH Excimer laser Investigator.
  • 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 with evidence of retinal vascular disease.
  • Subjects with any residual, recurrent, or active ocular disease, or corneal abnormality that in the Investigator's opinion would interfere with BSCVA or a successful treatment.
  • Subjects with signs of keratoconus.
  • Subjects with unstable central keratometry readings with irregular mires.
  • 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.
  • Subjects who have a history of Herpes simplex or Herpes zoster keratitis.
  • Subjects who have a history of glaucoma or glaucoma suspect.
  • Subjects who are immunocompromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
  • Subjects taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
  • Subjects who are known to be pregnant, lactating, or who plan to become pregnant during the course of the study.
  • Subjects with known sensitivity to medications used for standard LASIK.
  • Subjects participating in any other ophthalmic clinical trials during this clinical trial.
  • Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
  • Subjects at risk for angle closure.

Exclusion Criteria-For Fellow (Second) Eyes in Simultaneous Bilateral Treatment


  • Flap complications during the first eye's surgery such as a free cap, partial flap, thin flap, or irregular flap.
  • Epithelial defect exceeding 2mm x 2mm in dimension, or clinically significant debris in the interface between the flap and underlying stroma for the first eye.
  • Severe blepharospasm in the first eye that may have prevented or impeded the completion of the keratectomy and/or the laser ablation procedure.
  • Poor subject cooperation with instructions for the first eye's surgery and/or poor subject fixation on the laser fixation target.
  • Aborted LASIK procedure in the first eye or PRK or Epi-LASIK was performed in the first eye because LASIK was not possible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00910403

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Dr. Roure
Nice, France, 06000
Vision Future Nice
Nice, France, 06000
Clinique de la Vision Paris
Paris, France, 75007
Instituo Oftalmologico Casteanera
Barcelona, Spain, 08006
Sponsors and Collaborators
Technolas Perfect Vision GmbH
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Principal Investigator: Jean-Jacques Chaubard, Dr. VisionFuture / Nice
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Responsible Party: Dr. Gerhard Youssefi / VP Research & Clinical Operations, Technolas PerfectVision Identifier: NCT00910403    
Other Study ID Numbers: 0901
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: May 2011
Keywords provided by Technolas Perfect Vision GmbH:
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases