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Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System

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ClinicalTrials.gov Identifier: NCT02806726
Recruitment Status : Terminated (Decision to discontinue product development at this time)
First Posted : June 21, 2016
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
A prospective study to evaluate the feasibility of a new treatment algorithm to increase depth of focus after wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System. The purpose of this study is to determine whether wavefront-guided LASIK correction of myopic refractive errors with CustomVue combined with iDesign 1.3-PRESBY (presbyT-LASIK) treatments mitigate the effects of presbyopia by increasing the depth of focus compared to iDesign CustomVue treatments.

Condition or disease Intervention/treatment Phase
Presbyopia Myopia Device: iDesign 1.3-PRESBY treatment Device: iDesign 1.3 treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm to Increase Depth of Focus After Wavefront-guided LASIK Correction of Myopic Refractive Errors With the iDesign System and Star S4 IR™ Excimer Laser System
Actual Study Start Date : July 13, 2016
Actual Primary Completion Date : November 9, 2017
Actual Study Completion Date : November 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iDesign 1.3-PRESBY
iDesign 1.3-PRESBY in one eye of subject (experimental) is used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.
Device: iDesign 1.3-PRESBY treatment
Software used to calculate the LASIK treatment profile including a presbyopic correction component for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.

Active Comparator: iDesign 1.3
iDesign 1.3 in one eye of subject (control) is used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.
Device: iDesign 1.3 treatment
Software used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.




Primary Outcome Measures :
  1. Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm [ Time Frame: 6 months ]
    Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).


Secondary Outcome Measures :
  1. Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm [ Time Frame: 6 months ]
    Mean distance corrected near visual acuity (DCNVA) for PresbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All criteria apply to each eye

  1. Signed informed consent and Personal Health Information Protection Act authorization.
  2. At least 45 years of age at enrollment (date informed consent signed).
  3. The refractive error, based on the iDesign displayed refraction selected for treatment ("4.0 Rx calc" at 12.5 mm), must be myopia with or without astigmatism with sphere up to -6.00 D, and cylinder between 0.00 D and -5.00 D with a maximum spherical equivalent (SE) of -8.00 D.
  4. Require an add power of +1.00 D or more during near testing at 40 cm.
  5. Anticipated stromal bed thickness of at least 250 microns based on preoperative central corneal pachymetry minus the maximum ablation depth (as calculated by the iDesign system) plus the intended flap thickness.
  6. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
  7. Uncorrected Visual Acuity (UCVA) of 20/40 or worse.
  8. Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
  9. A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤1.00 D in MRSE.
  10. Any eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following:

    1. Rigid contact lenses (toric or spherical) must be removed for at least 4 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability.
    2. Two consecutive refractions and keratometric readings must be conducted at least 7 days apart.
    3. Refractive stability is defined as a change of not more than 0.50 D in manifest refraction sphere and cylinder as well as mean keratometry between measurements.
    4. If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted prior to surgery.
  11. Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment, as follows:

    1. Spherical Equivalent: Magnitude of the difference is less than 0.625 D.
    2. Cylinder: Magnitude of the difference is less than or equal to 0.5 D.
    3. Cylinder Axis Tolerance: If either the manifest cylinder entered into the iDesign System or the iDesign cylinder selected for treatment is less than 0.5 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.5 D, the axis tolerance as determined by the iDesign system is linearly reduced from 15 (0.5 D) to 7.5 (7.0 D) based on the average magnitude of both cylinders. Note: If the axis tolerance is not in the calculated range, the iDesign system will produce a warning and this exam may not be used for treatment planning.
  12. Willing and capable of complying with follow-up examinations for the duration of the study.

Exclusion Criteria:

  1. Women who are pregnant, breast-feeding, intend to become pregnant, or are not using an adequate method of birth control [examples are any form of barrier contraception (such as condom or diaphragm with contraceptive cream/jelly), birth control pills, hormonal implant, IUD, abstinence or surgical sterilization (tubal ligation, hysterectomy or vasectomy)]. Note: Women who were pregnant or nursing may not be enrolled until 6 months after either delivery or have stopped nursing and there is documented refractive stability.
  2. Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.

    NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility.

  3. History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

    NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity, or control, will specifically exclude subjects from eligibility.

  4. Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
  5. History of prior intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1 mm from limbus), retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma.

    NOTE: Subjects with open angle glaucoma, regardless of medication regimen or control, or an IOP greater than 21 mmHg at screening, are specifically excluded from eligibility.

  6. Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.
  7. Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
  8. Desire to have monovision.
  9. Intolerance to multifocal correction based on questionnaire responses to contact lens trial.
  10. Participation in any other clinical study.

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 ClinicalTrials.gov identifier (NCT number): NCT02806726


Locations
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Canada, Manitoba
Image Plus Laser Eye Center
Winnipeg, Manitoba, Canada, R3C3J5
Canada, Ontario
University of Ottawa
Ottawa, Ontario, Canada, K1H 8L6
Crystal Clear Vision
Toronto, Ontario, Canada, M5R 2E3
Sponsors and Collaborators
Abbott Medical Optics
Investigators
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Study Director: Kendra Hileman Abbott Medical Optics
  Study Documents (Full-Text)

Documents provided by Abbott Medical Optics:
Study Protocol  [PDF] November 8, 2016
Statistical Analysis Plan  [PDF] November 10, 2015


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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02806726     History of Changes
Other Study ID Numbers: STAR-116-TOPS
First Posted: June 21, 2016    Key Record Dates
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases