Clinical trial NCT02675751: Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-guided PRK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and the Star S4 IR™ Excimer Laser System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Myopic Refractive Error, With or Without Astigmatism
Keywords: myopia
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2016-02-05
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: