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

NCT02806726 | Terminated Results FDA Device

• 1 other identifier: STAR-116-TOPS
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Presbyopia; Myopia

Outcome Measures

Primary Outcomes (1)

• Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm

  Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).

  6 months

Secondary Outcomes (1)

• Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm

  6 months

Study Arms (2)

iDesign 1.3-PRESBY

EXPERIMENTAL

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

iDesign 1.3

ACTIVE COMPARATOR

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

Interventions

iDesign 1.3-PRESBY treatment DEVICE

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.

iDesign 1.3-PRESBY

iDesign 1.3 treatment DEVICE

Software used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.

iDesign 1.3

Eligibility Criteria

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

You may qualify if:

• All criteria apply to each eye
• Signed informed consent and Personal Health Information Protection Act authorization.
• At least 45 years of age at enrollment (date informed consent signed).
• 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.
• Require an add power of +1.00 D or more during near testing at 40 cm.
• 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.
• Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
• Uncorrected Visual Acuity (UCVA) of 20/40 or worse.
• Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
• 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.
• Any eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following:
• 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.
• Two consecutive refractions and keratometric readings must be conducted at least 7 days apart.
• 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.
• If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted prior to surgery.

You may not qualify if:

• 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.
• 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.
• 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.
• Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
• 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.
• Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography.
• Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
• Desire to have monovision.
• Intolerance to multifocal correction based on questionnaire responses to contact lens trial.
• Participation in any other clinical study.

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Presbyopia; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Priya Janakiraman
• Organization: Johnson & Johnson Surgical Vision, Inc.

djanaki1@its.jnj.com

1 714 2478628

Study Officials

• Kendra Hileman

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 21, 2016
• Study Start: July 13, 2016
• Primary Completion: November 9, 2017
• Study Completion: November 9, 2017
• Last Updated: February 4, 2025
• Results First Posted: February 8, 2019

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share