Higher Order Aberration and Relationship With Soft Contact Lens Modulus

Corneal Wavefront Aberration Clinical Trial

Official title:

Higher Order Aberration and Relationship With Soft Contact Lens Modulus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425432
• Other study ID #: 6733
• Status: Not yet recruiting
• Start date: May 20, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Southern College of Optometry
• Contact: Yueren Wang, OD
• Phone: 901-252-3691
• Email: ywang[@]sco.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Multifocal soft CL wear

• GP or ortho K wear in the last 3 months.

• Active eye infections and inflammations.

• Current use of ocular medication.

Related Conditions & MeSH terms

• Corneal Wavefront Aberration

Intervention

Device:
• OVITZ xwave aberrometer
wavefront aberrometer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southern College of Optometry

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between contact lens modulus and changes in HOA with and without contact lenses	Evaluate correlation between the lens modulus and changes in HOA	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.