COMPLETED

Characterization of the Central and Peripheral Wavefront Aberration Profile in Pediatric Myopic Subjects

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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 is a 3-visit, single site, observational clinical study to evaluate the characterization of the central and peripheral wavefront aberration profiles in pediatric myopic subjects.

Official Title

Characterization of the Central and Peripheral Wavefront Aberration Profile in Pediatric Myopic Subjects

Quick Facts

Study Start:2023-11-16

Study Completion:2025-08-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06075576

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:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Read or (be read to) and sign the CHILDREN'S ASSENT (information and assessment form) and receive a fully executed copy of the form. 2. Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT FORM and receive a fully executed copy of the form. 3. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 4. Be at least 6 years of age and not greater than 17 years of age at the time of consent. 5. The subjects are required to be within -1.00 to -6.00 D (inclusive) for the spherical component of vertex- corrected refraction. 6. The magnitude of cylindrical component of the subject's vertex distance corrected distance refraction must be between 0.00 and 2.25 D in each eye. 7. The subject must have distance best corrected visual acuity of 20/25 or better in each eye.	1. Be currently pregnant or lactating. 2. Be diabetic. 3. Be currently using any ocular medications or have any ocular infection of any type. 4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that may otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months. 6. History of pharmacologic treatment for myopia within the past 2 years. 7. Have participated in any study using pharmacologic agents within 30 days prior to study enrollment. 8. Use of any ocular medication, except for rewetting drops. 9. Have a history of pathological dry eye. 10. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 11. Have any known hypersensitivity or allergic reaction to rewetting drop solutions, topical anesthetic (Proparacaine), topical cycloplegic drops (Tropicamide) or sodium fluorescein. 12. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 13. Have a history of strabismus or amblyopia. 14. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 15. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.). 16. Intraocular pressure \>21 mm of Hg OD or OS. 17. Ocular anterior chamber angle assessed by Van Herick's measurement of grade 2 or less OD or OS. 18. Have latent, manifest nystagmus or any fixation related abnormality (at the discretion of the investigator). 19. Have any corneal scar and/or distortion within the central 6 mm.

Inclusion Criteria

Exclusion Criteria

1. Read or (be read to) and sign the CHILDREN'S ASSENT (information and assessment form) and receive a fully executed copy of the form.
2. Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT FORM and receive a fully executed copy of the form.
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. Be at least 6 years of age and not greater than 17 years of age at the time of consent.
5. The subjects are required to be within -1.00 to -6.00 D (inclusive) for the spherical component of vertex- corrected refraction.
6. The magnitude of cylindrical component of the subject's vertex distance corrected distance refraction must be between 0.00 and 2.25 D in each eye.
7. The subject must have distance best corrected visual acuity of 20/25 or better in each eye.

1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have any ocular infection of any type.
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that may otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
6. History of pharmacologic treatment for myopia within the past 2 years.
7. Have participated in any study using pharmacologic agents within 30 days prior to study enrollment.
8. Use of any ocular medication, except for rewetting drops.
9. Have a history of pathological dry eye.
10. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
11. Have any known hypersensitivity or allergic reaction to rewetting drop solutions, topical anesthetic (Proparacaine), topical cycloplegic drops (Tropicamide) or sodium fluorescein.
12. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
13. Have a history of strabismus or amblyopia.
14. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
15. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
16. Intraocular pressure \>21 mm of Hg OD or OS.
17. Ocular anterior chamber angle assessed by Van Herick's measurement of grade 2 or less OD or OS.
18. Have latent, manifest nystagmus or any fixation related abnormality (at the discretion of the investigator).
19. Have any corneal scar and/or distortion within the central 6 mm.

Contacts and Locations

Principal Investigator

Johnson & Johnson Vision Care, Inc. Clinical Trial

STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Study Locations (Sites)

University of Houston College of Optometry - J. Armistead Bldg Room 2195

Houston, Texas, 77204

United States

Collaborators and Investigators

Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc. Clinical Trial, STUDY_DIRECTOR, Johnson & Johnson Vision Care, Inc.

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 Date2023-11-16

Study Completion Date2025-08-11

Study Record Updates

Study Start Date2023-11-16

Study Completion Date2025-08-11

Terms related to this study

Additional Relevant MeSH Terms

Myopia