Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

Refractive Error Clinical Trial

Official title:

Post-approval Study of Wavefront-guided LASIK for Monovision Treatment of Myopic Subjects With Presbyopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075591
• Other study ID #: STAR-122-MVPM
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: AMO Development, LLC
• Contact: Study Contact
• Phone: +1 949 7042580
• Email: DParizad[@]ITS.JNJ.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a 12-month, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation conducted at 8 to 14 sites. A total of 383 subjects will be enrolled to achieve approximately 268 treated subjects, resulting in at least 241 evaluable subjects at the point of refractive stability. After signing the informed consent, subjects meeting all inclusion and exclusion criteria in both eyes may be scheduled for surgery. The follow-up visit schedule will be the same for each operative eye.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 383
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent and HIPAA authorization.

2. At least 40 years of age at enrollment (date informed consent signed).

3. The refractive error of both subject's eyes, based on the iDesign refraction selected for treatment ("4.0 mm Rx calc" at 12.5 mm), must be myopic with or without astigmatism up to -6.00 D spherical equivalent (SE), with cylinder up to -3.00 D and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopic retention.

4. At least one eye must require a myopic treatment.

5. Anticipated stromal bed thickness of at least 250 microns based on preoperative central corneal pachymetry minus the maximum treatment depth to be ablated (as calculated by the iDesign plus the intended flap thickness).

6. Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.

7. Require an add power of +1.25 D or more but not greater than +2.00 D at 40 cm.

8. Less than or equal to ±0.50 D difference between cycloplegic and manifest refraction sphere.

9. A stable refractive error (based on a previous exam, medical records, lensometry, or prescription that is at least 12 months prior to the preoperative manifest refraction), as defined by a change of less than or equal to

• 0.50 D in MRSE (sphere and cylinder).

10. Subjects with a history of contact lens wear within the last 4 weeks must discontinue lens wear in order to demonstrate refractive stability according to the following (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): After the Informed Consent process has been completed and subjects are enrolled in the

study:

• Rigid or extended wear contact lenses (toric or spherical) must be removed for at least 3 weeks and soft contact lenses (toric or spherical) for at least 2 weeks prior to the first refraction used to establish stability.
• After abstaining from contact lens wear for designated time, two consecutive manifest refractions and keratometric readings must be conducted at least 7 days apart
• I If the subject/eye meets the refractive stability criteria, contact lens wear is not permitted for 2 weeks prior to surgery except as required to test monovision acceptance as described below in the Study Procedures, Contact Lens Trial section NOTE: Refractive stability needs to be confirmed only once during preoperative assessment

11. Agreement between manifest refraction (adjusted for optical infinity) and iDesign

System refraction chosen for treatment, as follows:

• Spherical Equivalent: magnitude of the difference is less than 0.625 D.
• Cylinder: magnitude of the difference is less than or equal to 0.5 D.
• 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 agreement. 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 degrees (0.5 D) to 7.5 degrees (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, or intend to become pregnant during the study. 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, within the past 6 months 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, prior strabismus surgery, strabismus, or at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma or suspected glaucoma. NOTE: Subjects with 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. Intolerance to monovision correction based on questionnaire responses to contact lens trial (refer to section Study Procedures, Contact Lens Trial below).

9. Concurrent participation in any other clinical trial, or participation in any other clinical trial within the last 14 days.

Related Conditions & MeSH terms

• Presbyopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• iDesign Refractive Studio with STAR S4 IR® Excimer laser System
Surgeons will perform wavefront-guided monovision LASIK for the treatment of myopic subjects with presbyopia based upon measurements obtained with an iDesign Refractive Studio.

Locations

Country	Name	City	State
United States	Coleman Vision	Albuquerque	New Mexico
United States	Kraff Eye Institute	Chicago	Illinois
United States	The Eye Center	Fairfax	Virginia
United States	Loden Vision Centers	Goodlettsville	Tennessee
United States	Berkeley Eye Institute, P.A.	Houston	Texas
United States	Texas Eye & Laser Center	Hurst	Texas
United States	Center for Sight	Las Vegas	Nevada
United States	Maloney Vision Institute	Los Angeles	California
United States	Utah Eye Center	Ogden	Utah
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
AMO Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in driving scale score from preoperative to postoperative as measured by the driving scale within the PROWL-M (Patient-Reported Outcomes with LASIK for monovision) questionnaire	To assess the effect of monovision LASIK treatment on difficulty with driving as measured by the driving scale within the PROWL-M (Patient-Reported Outcomes with LASIK for monovision) questionnaire	12 months
Primary	The proportion of subjects who required secondary surgery to reverse monovision	The proportion of subjects who required secondary surgery to reverse monovision will be reported.	12 months