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Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™

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Abbott

Status

Completed

Conditions

Stable Myopic Refractive Error, With or Without Astigmatism

Treatments

Device: STAR S4 IR laser with iDesign

Study type

Interventional

Funder types

Industry

Identifiers

NCT02675751
STAR-115-MIPS

Details and patient eligibility

About

Prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.

Enrollment

167 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

NOTE: Enrollment open only to military personnel

Inclusion Criteria:

  • Signed informed consent and HIPAA authorization.
  • Refractive error, based on the iDesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D with maximum SE of -10.00 D.
  • Anticipated residual stromal bed thickness of at least 250 microns as calculated by the iDesign system.
  • Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
  • BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
  • Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
  • Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12 month time period.
  • Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability
  • Agreement between manifest refraction (adjusted for optical infinity) and iDesign System refraction chosen for treatment.
  • Willing and capable of complying with follow-up examinations for the duration of the study.

Exclusion Criteria:

  • Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control.
  • Concurrent use of systemic (including inhaled) medications that may impair healing.
  • 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.
  • Subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
  • History of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, 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.
  • Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography
  • Known sensitivity or inappropriate responsiveness to any of the medications used in this study.
  • If either eye does not meet all inclusion criteria
  • Desire to have monovision.
  • Participation in any other clinical study, with the exception of the fellow eye in this study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

167 participants in 1 patient group

wavefront-guided PRK with iDesign
Experimental group
Description:
wavefront-guided PRK for treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser
Treatment:
Device: STAR S4 IR laser with iDesign

Trial documents
2

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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