## Protocol Section
### Identification Module
**NCT ID:** NCT06425432

**Brief Title:** Higher Order Aberration and Relationship With Soft Contact Lens Modulus

**Official Title:** Higher Order Aberration and Relationship With Soft Contact Lens Modulus

#### Organization Study ID Info
**ID:** 6733
#### Organization
**Class:** OTHER
**Full Name:** Southern College of Optometry
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Southern College of Optometry

#### Responsible Party

**Investigator Affiliation:** Southern College of Optometry

**Investigator Full Name:** Yueren Wang, OD

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Corneal Wavefront Aberration

**Keywords:**

- Contact Lens

- Higher order aberration

- Modulus

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: OVITZ xwave aberrometer

**Label:** CL first

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: OVITZ xwave aberrometer

**Label:** Glasses first

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CL first

- Glasses first

**Description:** wavefront aberrometer

**Name:** OVITZ xwave aberrometer

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Measure HOA with contact lenses. And then measure HOA without contact lenses.

**Measure:** Mean change in HOA with and without contact lenses

**Time Frame:** 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

**Description:** Evaluate correlation between the lens modulus and changes in HOA

**Measure:** Correlation between contact lens modulus and changes in HOA with and without contact lenses

**Time Frame:** 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.

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ywang@sco.edu

**Name:** Yueren Wang, OD

**Phone:** 901-252-3691

**Role:** CONTACT

### IPD Sharing Statement Module

**Access Criteria:** Upon request

**Description:** all IPD that underlie results in a publication

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** 6 months - 3 years after publication

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-05-13

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 197197

- Type Abbrev: Prot

- Upload Date: 2024-05-20T13:06

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003316

- Term: Corneal Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000012030

- Term: Refractive Errors

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M28721

- Name: Corneal Wavefront Aberration

- Relevance: HIGH

- As Found: Corneal Wavefront Aberration

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14872

- Name: Refractive Errors

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000057108

- Term: Corneal Wavefront Aberration

### Misc Info Module

- Version Holder: 2024-05-31
