Corneal Wavefront AberrationNCT06425432
Higher Order Aberration and Relationship With Soft Contact Lens Modulus
An observational study of Corneal Wavefront Aberration, run by Southern College of Optometry.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Wavefront Aberration
- What is being tested?
- OVITZ xwave aberrometer
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (>18 years old) who are wearing single-vision soft contact lenses will be recruited.
Who may be able to join
- 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.
Who cannot join
- Multifocal soft CL wear
- GP or ortho K wear in the last 3 months.
- Active eye infections and inflammations.
- Current use of ocular medication.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- OVITZ xwave aberrometer
- Keywords
- Contact Lens, Higher order aberration, Modulus
- Medical subject headings
- Corneal Wavefront Aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVITZ xwave aberrometerDevice
wavefront aberrometer
| Study group | Role | What they receive |
|---|---|---|
| CL first | Subject will present wearing habitual contact lenses for the aberrometry measurement. They will then remove their contact lenses and measurement repeated uncorrected. Receives: 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. Receives: Device: OVITZ xwave aberrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in HOA with and without contact lenses
Measure HOA with contact lenses. And then measure HOA without contact lenses.
Measured: 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
Evaluate correlation between the lens modulus and changes in HOA
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start20 May 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Wavefront AberrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueren Wang, OD, Southern College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425432
- Sponsor's protocol ID
- 6733
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Order Aberration and Relationship With Soft Contact Lens Modulus
- ClinicalTrials.gov ID
- NCT06425432
- Acronym / sponsor ID
- 6733
- Conditions
- Corneal Wavefront Aberration
- Keywords
- Contact Lens, Higher order aberration, Modulus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CL first | – | Device: OVITZ xwave aberrometerSubject will present wearing habitual contact lenses for the aberrometry measurement. They will then remove their contact lenses and measurement repeated uncorrected. |
| Glasses first | – | Device: OVITZ xwave aberrometerSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (>18 years old) who are wearing single-vision soft contact lenses will be recruited.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Multifocal soft CL wear
- GP or ortho K wear in the last 3 months.
- Active eye infections and inflammations.
- Current use of ocular medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVITZ xwave aberrometerwavefront aberrometer | Device | CL first, Glasses first |
Primary outcome
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.
Measure HOA with contact lenses. And then measure HOA without contact lenses.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Corneal Wavefront Aberration
Not yet recruiting
Factors Influencing Subjective Visual Quality in Human Eyes
Corneal Wavefront Aberration, Refractive Errors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Wavefront Aberration, run by Southern College of Optometry.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueren Wang, OD (901-252-3691, ywang@sco.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.