Higher Order Aberration and Relationship With Soft Contact Lens Modulus

NCT06425432 | Not Yet Recruiting FDA Device

• 1 other identifier: 6733
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Higher order aberrations are imperfects in the eye that affect the quality of image projected onto the retina. Soft contact lenses are made of different materials with different stiffness. This study looks to see if the soft contact lens material affects the amount of higher order aberrations in an eye.

Conditions

Corneal Wavefront Aberration

Keywords

Contact Lens; Higher order aberration; Modulus

Outcome Measures

Primary Outcomes (1)

• Mean change in HOA with and without contact lenses

  Measure HOA with contact lenses. And then measure HOA without contact lenses.

  Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.

Secondary Outcomes (1)

• Correlation between contact lens modulus and changes in HOA with and without contact lenses

  Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.

Study Arms (2)

CL first

Subject will present wearing habitual contact lenses for the aberrometry measurement. They will then remove their contact lenses and measurement repeated uncorrected.

Device: OVITZ xwave aberrometer

Glasses first

Subjects will refrain from contact lens wear on day of the visit. Initial aberrometry measurement will be performed uncorrected. They will be then asked to insert their contact lenses and aberrometry measurements repeated.

Device: OVITZ xwave aberrometer

Interventions

OVITZ xwave aberrometer DEVICE

wavefront aberrometer

CL first; Glasses first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (\>18 years old) who are wearing single-vision soft contact lenses will be recruited.

You may qualify if:

• Willing and able to provide informed consent
• Adults \> 18 years old regardless of gender, race, or ethnicity
• Habitual single vision soft CL wearer for at least 1 week in any modality.

You may not qualify if:

• Multifocal soft CL wear
• GP or ortho K wear in the last 3 months.
• Active eye infections and inflammations.
• Current use of ocular medication.

Sponsors & Collaborators

• Southern College of Optometry: lead

MeSH Terms

Conditions

Corneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Refractive Errors

Central Study Contacts

Yueren Wang, OD

CONTACT

901-252-3691; ywang@sco.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 22, 2024
• Study Start: May 20, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months - 3 years after publication
• Access Criteria: Upon request