NearsightednessNCT03479827
Measuring the Peripheral Optical Quality of The Eye
An observational study of Nearsightedness, run by University of Rochester at 1 site in United States.
Trial summary
The goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. This will enable us to investigate the impact of the aberration on retinal image quality. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nearsightedness
- What is being tested?
- Monofocal Contact Lens and Bifocal Contact Lens
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 29 Nov 2020
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults with no ocular pathology and uses contact lenses.
Who may be able to join
- A person will be included in the study if he/she:
- Is 18 years or older and has full legal capacity to volunteer.
- Has no ocular condition or pathology, which may impact visual acuity e.g. keratoconus, amblyopia, cataract, macular degeneration;
- Has no active ocular disease or allergic conjunctivitis;
- Is not using any topical ocular medications;
- Is willing and able to follow instructions;
- Has voluntarily agreed to participate in the study by signing the statement of informed consent.
Who cannot join
- A person will be excluded from the study if he/she:
- Is under the age of 18 or over the age of 60 yrs.
- Correctable with high contrast logMAR acuity (EDTRS) testing to 20/20 or better;
- Pregnant at the time of enrolment in the study;
- Unable to handle, insert, remove or care for the study lenses;
- Considered by the Investigator to not be a suitable candidate for participation.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. This will enable us to investigate the impact of the aberration on retinal image quality.
Read the detailed description
The goal of this study is to investigate the effects of monofocal and bifocal soft contact lenses in the changes of peripheral optical quality and through-focus visual performance on real eyes. The goal will be accomplished by performing optical measurements using Shack-Hartmann wavefront sensor with and without the use of single vision and bifocal soft contact lenses.
- Conditions
- Nearsightedness
- Being tested
- Monofocal Contact Lens, Bifocal Contact Lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofocal Contact LensDevice
A monofocal contact lens will be used for this measurement.
Bifocal Contact LensDevice
A bifocal contact lens will be used for this measurement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Subjects will undergo three Wavefront measurements, once with no contact lens, once with a monofocal contact lens and once with a bifocal contact lens. Receives: Device: Monofocal Contact Lens; Device: Bifocal Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Wavefront aberrations
The scanning wavefront sensor will be used to collect data. Mean Wavefront aberrations for each trail will be analyzed.
Measured: less than 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start31 Aug 2018
- Primary completion29 Nov 2020
- Study completion29 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NearsightednessStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geunyoung Yoon, University of Rochester
- Investigators
- Geunyoung Yoon, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479827
- Sponsor's protocol ID
- 71201
- Status last verified
- Aug 2022
- First submitted
- 27 Feb 2018
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Peripheral Optical Quality of The Eye
- ClinicalTrials.gov ID
- NCT03479827
- Acronym / sponsor ID
- 71201
- Conditions
- Nearsightedness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 29 Nov 2020 (actual)
- First posted
- 27 Mar 2018 (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.
The goal of the study is to quantify wavefront aberration profiles of the eye with and without contact lens across the visual field. This will enable us to investigate the impact of the aberration on retinal image quality.
Detailed description
The goal of this study is to investigate the effects of monofocal and bifocal soft contact lenses in the changes of peripheral optical quality and through-focus visual performance on real eyes. The goal will be accomplished by performing optical measurements using Shack-Hartmann wavefront sensor with and without the use of single vision and bifocal soft contact lenses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Device: Monofocal Contact Lens, Device: Bifocal Contact LensSubjects will undergo three Wavefront measurements, once with no contact lens, once with a monofocal contact lens and once with a bifocal contact lens. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults with no ocular pathology and uses contact lenses.
Key inclusion criteria (7 listed)
- Is 18 years or older and has full legal capacity to volunteer.
- Has no ocular condition or pathology, which may impact visual acuity e.g. keratoconus, amblyopia, cataract, macular degeneration;
- Has no active ocular disease or allergic conjunctivitis;
- Is not using any topical ocular medications;
- Is willing and able to follow instructions;
Key exclusion criteria (6 listed)
- Is under the age of 18 or over the age of 60 yrs.
- Correctable with high contrast logMAR acuity (EDTRS) testing to 20/20 or better;
- Pregnant at the time of enrolment in the study;
- Unable to handle, insert, remove or care for the study lenses;
- Considered by the Investigator to not be a suitable candidate for participation.
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 |
|---|---|---|
| Monofocal Contact LensA monofocal contact lens will be used for this measurement. | Device | Experimental |
| Bifocal Contact LensA bifocal contact lens will be used for this measurement. | Device | Experimental |
Primary outcome
Mean Wavefront aberrations
Time frame: less than 2 hours
The scanning wavefront sensor will be used to collect data. Mean Wavefront aberrations for each trail will be analyzed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Geunyoung Yoon, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nearsightedness, run by University of Rochester at 1 site in United States.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Wavefront aberrations (time frame: less than 2 hours). 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 16 Aug 2022.