MyopiaNCT03705130
Evaluation of Visual Performance With Contact Lenses
An observational study of Myopia, run by University of Houston at 1 site in United States.
Trial summary
This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Single Vision Contact Lens, Multifocal Contact Lens 1 and Multifocal Contact Lens 2
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 26 Jul 2018
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects between the ages of 18-39 (inclusive) without significant ocular disease.
Who may be able to join
- 18 to 39 years of age
- Best corrected visual acuity of at least 20/30
- Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters sphere after vertexing to the corneal plane
Who cannot join
- Greater than -1.00 diopter of refractive astigmatism at the corneal plane
- Any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a soft contact lens
- History of ocular trauma or surgery causing abnormal or distorted vision
- Current Rigid Gas Permeable (RGP) contact lens wearers
- Unwilling to have eyes photographed or video recorded
- Pregnant and/or lactating females, by self-report
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).
Read the detailed description
The study will examine visual acuity with various contact lenses, with and without glare source, in myopes between the ages of 18-39 years old (inclusive) to determine the effect of different multifocal optical designs on visual performance in the post-fit period.
- Conditions
- Myopia
- Being tested
- Single Vision Contact Lens, Multifocal Contact Lens 1, Multifocal Contact Lens 2
- Keywords
- Multifocal Contact Lens, Myopia, Visual Performance
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Vision Contact LensDevice
Also called comfilcon A
Spherical Contact Lens worn on non-dispensing basis
Multifocal Contact Lens 1Device
Also called comfilcon A
Multifocal Contact Lens worn on non-dispensing basis
Multifocal Contact Lens 2Device
Also called etafilcon A
Multifocal Contact Lens worn on non-dispensing basis
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | All subjects will wear the 3 contact lenses: Single Vision, Multifocal 1 and Multifocal 2. Receives: Device: Single Vision Contact Lens; Device: Multifocal Contact Lens 1; Device: Multifocal Contact Lens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Contrast Visual Acuity with Glare
Vision with contact lenses measured under low illumination conditions with glare source
Measured: Through study completion, an average of 3 hours
Secondary outcomes (1)
Low Contrast Visual Acuity without Glare
Vision with contact lenses measured under low illumination conditions without glare source
Measured: Through study completion, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start14 Jun 2018
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric R. Ritchey, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705130
- Sponsor's protocol ID
- STUDY00000958
- Status last verified
- Oct 2018
- First submitted
- 14 Jun 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nti AN, Gregory HR, Ritchey ER, Wolffsohn JS, Berntsen DA. Contrast Sensitivity with Center-distance Multifocal Soft Contact Lenses. Optom Vis Sci. 2022 Apr 1;99(4):342-349. doi: 10.1097/OPX.0000000000001874.
PubMed 35121719
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Performance With Contact Lenses
- ClinicalTrials.gov ID
- NCT03705130
- Acronym / sponsor ID
- STUDY00000958
- Conditions
- Myopia
- Keywords
- Multifocal Contact Lens, Myopia, Visual Performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 15 Oct 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.
This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).
Detailed description
The study will examine visual acuity with various contact lenses, with and without glare source, in myopes between the ages of 18-39 years old (inclusive) to determine the effect of different multifocal optical designs on visual performance in the post-fit period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Single Vision Contact Lens, Device: Multifocal Contact Lens 1, Device: Multifocal Contact Lens 2All subjects will wear the 3 contact lenses: Single Vision, Multifocal 1 and Multifocal 2. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects between the ages of 18-39 (inclusive) without significant ocular disease.
Key inclusion criteria (3 listed)
- 18 to 39 years of age
- Best corrected visual acuity of at least 20/30
- Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters sphere after vertexing to the corneal plane
Key exclusion criteria (6 listed)
- Greater than -1.00 diopter of refractive astigmatism at the corneal plane
- Any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a soft contact lens
- History of ocular trauma or surgery causing abnormal or distorted vision
- Current Rigid Gas Permeable (RGP) contact lens wearers
- Unwilling to have eyes photographed or video recorded
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 |
|---|---|---|
| Single Vision Contact LensAlso: comfilcon ASpherical Contact Lens worn on non-dispensing basis | Device | Group 1 |
| Multifocal Contact Lens 1Also: comfilcon AMultifocal Contact Lens worn on non-dispensing basis | Device | Group 1 |
| Multifocal Contact Lens 2Also: etafilcon AMultifocal Contact Lens worn on non-dispensing basis | Device | Group 1 |
Primary outcome
Low Contrast Visual Acuity with Glare
Time frame: Through study completion, an average of 3 hours
Vision with contact lenses measured under low illumination conditions with glare source
1 secondary outcome
Low Contrast Visual Acuity without Glare
Time frame: Through study completion, an average of 3 hours
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 15 Oct 2018.
- Derived from this study: PubMed 35121719Nti AN, Gregory HR, Ritchey ER, Wolffsohn JS, Berntsen DA. Contrast Sensitivity with Center-distance Multifocal Soft Contact Lenses. Optom Vis Sci. 2022 Apr 1;99(4):342-349. doi: 10.1097/OPX.0000000000001874.
- Individual participant dataSharing planned: No
Related trials for Myopia
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myopia, run by University of Houston 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 3 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 15 Oct 2018. 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?
Low Contrast Visual Acuity with Glare (time frame: Through study completion, an average of 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705130, which also lists 1 linked publication.
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 15 Oct 2018.