Higher Order Aberration and Relationship With Soft Contact Lens Modulus

Not yet recruiting

• Conditions: Corneal Wavefront Aberration
• Interventions: Device: OVITZ xwave aberrometer

• Registration Number: NCT06425432
• Lead Sponsor: Southern College of Optometry

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study Start: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CL first	OVITZ xwave aberrometer	Subject will present wearing habitual contact lenses for the aberrometry measurement. They will then remove their contact lenses and measurement repeated uncorrected.
Glasses first	OVITZ xwave aberrometer	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.

Primary Outcome Measures

Name	Time	Method
Mean change 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.	Measure HOA with contact lenses. And then measure HOA without contact lenses.

Secondary Outcome Measures

Name	Time	Method
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.	Evaluate correlation between the lens modulus and changes in HOA