COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-09-24

Study Completion:2025-06-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04075591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	1. Women who are pregnant, breast-feeding, or intend to become pregnant during the study. 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. 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. 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.

Inclusion Criteria

Exclusion 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.

1. Women who are pregnant, breast-feeding, or intend to become pregnant during the study.
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.
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.
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.

Contacts and Locations

Principal Investigator

AMO Development, LLC Clinical Trial

STUDY_DIRECTOR

AMO Development, LLC

Study Locations (Sites)

Maloney Vision Institute

Los Angeles, California, 90024

United States

Kraff Eye Institute

Chicago, Illinois, 60602

United States

Center for Sight

Las Vegas, Nevada, 89145

United States

Coleman Vision

Albuquerque, New Mexico, 87109

United States

Vance Thompson Vision

Sioux Falls, South Dakota, 57108

United States

Loden Vision Centers

Goodlettsville, Tennessee, 37072

United States

Berkeley Eye Institute, P.A.

Houston, Texas, 77027

United States

Texas Eye & Laser Center

Hurst, Texas, 76054

United States

Utah Eye Center

Ogden, Utah, 84403

United States

The Eye Center

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: AMO Development, LLC

AMO Development, LLC Clinical Trial, STUDY_DIRECTOR, AMO Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-24

Study Completion Date2025-06-25

Study Record Updates

Study Start Date2019-09-24

Study Completion Date2025-06-25

Terms related to this study

Additional Relevant MeSH Terms

Refractive Error