AstigmatismNCT04772560
Toric Contact Lens Digital Performance and Comfort Study
A study testing Precision1 for Astigmatism and Precision1 Sphere in people with Astigmatism, run by Kathryn Richdale at 1 site in United States.
Trial summary
This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- Precision1 for Astigmatism and Precision1 Sphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 13 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 18 to 39 years of age (inclusive)
- pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS
- Current/established full time (>6 days week, >8 hours/day) soft contact lens wearer
- Best corrected acuity of 20/25 or better in each eye
- Self-report of at least 4 hrs/day using digital devices
- Willing to wear lenses at least 8 hours each day during the study period
Show all 12Show fewer
- Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)
- Enclusion Criteria:
- History of ocular pathology or surgery
- Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)
- Gas permeable lens wear for at least 3 months
- Symptomatic soft contact lens wearer (CLDEQ-8 score <12 at baseline)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston College of Optometry
Houston, Texas, 77204
About this study
This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.
Read the detailed description
This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections
- Conditions
- Astigmatism
- Being tested
- Precision1 for Astigmatism, Precision1 Sphere
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision1 for AstigmatismDevice
Daily disposable soft toric contact lens
Precision1 SphereDevice
Daily disposable soft spherical contact lens
| Study group | Role | What they receive |
|---|---|---|
| Toric, Then Sphere | Experimental | Participants who received Toric contact lenses first and spherical lenses after 10 days Receives: Device: Precision1 for Astigmatism; Device: Precision1 Sphere |
| Sphere, Then Toric | Experimental | Participants who received Spherical contact lenses first and Toric lenses after 10 days Receives: Device: Precision1 for Astigmatism; Device: Precision1 Sphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Visual LogMAR Acuity
High contrast LogMAR visual acuity was assessed at 40 cm using the M\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.
Measured: 10 +/- 2 days
Dynamic Visual Acuity
Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention
Measured: 10 +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start16 Mar 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AstigmatismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathryn Richdale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathryn Richdale, University of Houston
- Investigators
- Kathryn Richdale, Principal investigator, University of Houston College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772560
- Sponsor's protocol ID
- STUDY00002753
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2021
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toric Contact Lens Digital Performance and Comfort Study
- ClinicalTrials.gov ID
- NCT04772560
- Acronym / sponsor ID
- STUDY00002753
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kathryn RichdaleUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 10 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.
Detailed description
This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toric, Then Sphere | Experimental | Device: Precision1 for Astigmatism, Device: Precision1 SphereParticipants who received Toric contact lenses first and spherical lenses after 10 days |
| Sphere, Then Toric | Experimental | Device: Precision1 for Astigmatism, Device: Precision1 SphereParticipants who received Spherical contact lenses first and Toric lenses after 10 days |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18 to 39 years of age (inclusive)
- pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS
- Current/established full time (>6 days week, >8 hours/day) soft contact lens wearer
- Best corrected acuity of 20/25 or better in each eye
- Self-report of at least 4 hrs/day using digital devices
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Precision1 for AstigmatismDaily disposable soft toric contact lens | Device | Sphere, Then Toric, Toric, Then Sphere |
| Precision1 SphereDaily disposable soft spherical contact lens | Device | Sphere, Then Toric, Toric, Then Sphere |
Primary outcome
Near Visual LogMAR Acuity
Time frame: 10 +/- 2 days
High contrast LogMAR visual acuity was assessed at 40 cm using the M\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.
Dynamic Visual Acuity
Time frame: 10 +/- 2 days
Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Astigmatism
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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.
Kathryn Richdale principal investigator
University of Houston College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision1 for Astigmatism and Precision1 Sphere in people with Astigmatism, run by Kathryn Richdale 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 12 inclusion and 0 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 10 Mar 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?
Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Near Visual LogMAR Acuity (time frame: 10 +/- 2 days). The study lists 2 primary outcomes in all. 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 10 Mar 2022.