Binocular Vision DisorderNCT05070767
Neurolens Headache Study
A study testing Neurolens spectacle lens in people with Binocular Vision Disorder and Convergence Insufficiency, run by Neurolens Inc. at 10 sites in United States.
Trial summary
To understand the benefits of the neurolens Measurement Device and neurolens treatment as it pertains to treating symptoms related to Chronic Headaches. It is a Prospective randomized double masked two arm performed on a minimum of 200 to a maximum of 300 subjects identified as symptomatic (HIT-6 questionnaire score… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Binocular Vision Disorder, Convergence Insufficiency, Headache
- What is being tested?
- Neurolens spectacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Oct 2021to 30 May 2022
- Phase
- Interventional
- 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
Who may be able to join
- Male or female, and between 18-60 years of age at the time of signing the informed consent.
- Best Corrected distance and near acuity are equal to or better than 20/25 Snellen Equivalent in each eye.
- Best Corrected distance and near binocular acuity are equal to or better than 20/25 Snellen Equivalent.
- Symptomatic as indicated by the HIT-6 questionnaire (Score equal to or greater than 56)
- Updated distance spectacle prescription must match the following
- Spherical power inclusive between +4.00D to -8.00D b. Cylinder power no more than -4.00Dcyl c. ADD power i. Subgroup 1: No ADD ii. Subgroup 2: minimum +1.00D ADD
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- Subjects' eye alignment tests must match the following:
- Successful measurement on the neurolens Measurement Device (Acceptable MQI and a numerical neurolens Value, no Low MQI or Convergence Excess)
- Minimum stereo vision of 50 seconds of arc at 16 inches
- Capable of committing to the duration of the study.
- Willing to comply with study procedures
Who cannot join
- Subjects who need a vertical prism.
- Previously has worn neurolenses.
- Subjects who need a near add less than 1.00D
- Use of contact lenses during the study
- Lack of binocular vision, including strabismus, amblyopia, or suppression.
- Greater than 20 prism diopter of eye misalignment.
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- Aniseikonia greater than 3.00D spherical equivalent difference between eyes
- Prior ocular surgery that in the estimation of the practitioner induces corneal scarring (RK, Corneal Transplant, etc.) or prior surgery involving the extraocular muscles (strabismus surgery). Surgeries that do not affect these parameters such as LASIK, PRK, or pterygium surgery are allowed.
- Anterior segment conditions that could obfuscate or obscure reflections from the cornea, or reduce visual acuity, including but not limited to corneal scarring, large pinguecula, pterygium, keratoconus, dermatochalasis, ptosis, exophthalmos or cataract.
- Clinical dry eye (defined as tear break-up time of less than 5 seconds)
- Intraocular pressures greater than 25 mmHg in either eye or uncontrolled glaucoma
- Macular disease, or any posterior segment finding which in the opinion of the investigator is visually and/or clinically significant
- Change in acute or prophylactic migraine treatment medication or dosage within the previous two months.
- Diabetes with ocular manifestation
- Previous head or neck trauma (for instance, car accident, etc.) requiring medical intervention.
- Open lesions or sores around the chin or eyes that will make contact with the device and may be subject to contraction or spread of infection.
- Physical tremors or muscle spasms that prevent a subject from sitting still.
- A history of seizures or seizure disorder.
- Women who are pregnant or lactating at the time of the study entry
- Mental incapacity that prevents a subject from being able to follow simple instructions such as "look at the target."
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Kapperman White and McGarvey
Chattanooga, Tennessee, 37421
The Eye Center
Conyers, Georgia, 30012
Buckeye Family Eye Clinic
Hillsboro, Ohio, 45133
Signature Eye Care
Lincoln, Nebraska, 68516
Preferred Eye Care Center
Mt. Pleasant, South Carolina, 29466
Advanced Eyecare Center
Perry, Georgia, 31069
Advanced Vision and Achievement Center
Phoenix, Arizona, 85051
Eyecare of Rigby
Rigby, Idaho, 83442
Eyes for Life
Spokane, Washington, 99203
Springhill Eye Care
Spring Hill, Tennessee, 37174
About this study
Official title: Randomized Controlled Double Masked Two Arm Cross-over Study of Neurolenses in Subjects With Headaches
To understand the benefits of the neurolens Measurement Device and neurolens treatment as it pertains to treating symptoms related to Chronic Headaches. It is a Prospective randomized double masked two arm performed on a minimum of 200 to a maximum of 300 subjects identified as symptomatic (HIT-6 questionnaire score equal to or greater than 56) done across 3-15 clinical sites. There are two subgroups: a minimum of 100 in each subgroup (subgroup 1: pre-presbyopic (18-40 years); subgroup 2: presbyopic subjects (41-60 years).
Read the detailed description
This study is a two-arm crossover study with two subgroups. Subjects will initially be assessed for their headache symptoms (Headache Impact Test (HIT-6) questionnaire) and then are provided an updated refractive prescription and will wear them for 35 ± 5 days. Symptoms will be reassessed after the 35-day control break in. If the subject's symptoms have subsided, they will be exited from the study and will keep their lenses. Provided the subject has symptoms (HIT questionnaire score ≥ 56) after their 35-day use of their updated prescription and they continue to meet the inclusion/exclusion criteria they will proceed to the evaluation portion of the protocol. The first arm receiving neurolens first and the second arm receiving the control first. The control is a single vision or PAL lens which yields the BCDVA and BCNVA of a test subject with no prismatic correction. The neurolens prescribed prism will be based on the practitioner's Rx using the subject's best response to a prism trial lens and must be within a half prism diopter of the neurolens value output of the neurolens Measurement Device and providing the subject's BCDVA and BCNVA. Participants will come back after 35 day wear of their first test lens and the symptom questionnaire is reassessed. They will be now be crossed over to the second pair of study lenses (i.e. subjects in the first arm will not receive control lens and the ones in the second arm will not receive neurolens). Participants will come back after 35 day wear of their second test lens and the symptom questionnaire is reassessed for the final time.
- Being tested
- Neurolens spectacle lens, Placebo spectacle lens
- Keywords
- headache, neurolenses, computer vision syndrome, convergence insufficiency, binocular vision, non-strabismic disorder, Digital vision syndrome
- Medical subject headings
- Ocular Motility Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurolens spectacle lensDevice
spectacle lens
Placebo spectacle lensDevice
spectacle lens for refractive error correction
| Study group | Role | What they receive |
|---|---|---|
| Neurolens | Experimental | Our proprietary contoured prism lens design, commercially known as neurolens. Receives: Device: Neurolens spectacle lens |
| Control lens | Placebo comparator | A simple refractive error correction lens Receives: Device: Placebo spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Impact Test (HIT-6) questionnaire
Change in headache impact test (HIT-6) with the use of neurolenses compared to control lenses.
The minimum response score for each question is 6 and the maximum is 13. Larger scores would indicate a more symptomatic patient.
Larger difference in the cumulative response score between treatment visit and the baseline visit would indicate a greater impact of the treatment.
Measured: 30-40 days
Secondary outcomes (1)
Patients with reduced near point of convergence (NPC)
Change in the headache impact test (HIT-6) score with the use of neurolens compared to control lenses in subjects with reduced Near point of convergence (NPC).
The minimum response score for each question is 6 and the maximum is 13. Larger scores would indicate a more symptomatic patient.
Larger difference in the cumulative response score between treatment visit and the baseline visit would indicate a greater impact of the treatment.
Measured: 30-40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start18 Oct 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binocular Vision DisorderStudies 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
- Model description
- Prospective randomized double masked two arm
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurolens Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corina Van De Pol, OD PhD, Study director, Neurolens Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070767
- Sponsor's protocol ID
- NLR - 210720
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2021
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We will be providing a backend read-only excel spreadsheet of the raw data that was entered on the digital data platform provided to the clinical site.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Double Masked Two Arm Cross-over Study of Neurolenses in Subjects With Headaches
- ClinicalTrials.gov ID
- NCT05070767
- Acronym / sponsor ID
- NLR - 210720
- Keywords
- headache, neurolenses, computer vision syndrome, convergence insufficiency, binocular vision, non-strabismic disorder, Digital vision syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Neurolens Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 7 Oct 2021 (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.
To understand the benefits of the neurolens Measurement Device and neurolens treatment as it pertains to treating symptoms related to Chronic Headaches. It is a Prospective randomized double masked two arm performed on a minimum of 200 to a maximum of 300 subjects identified as symptomatic (HIT-6 questionnaire score equal to or greater than 56) done across 3-15 clinical sites. There are two subgroups: a minimum of 100 in each subgroup (subgroup 1: pre-presbyopic (18-40 years); subgroup 2: presbyopic subjects (41-60 years).
Detailed description
This study is a two-arm crossover study with two subgroups. Subjects will initially be assessed for their headache symptoms (Headache Impact Test (HIT-6) questionnaire) and then are provided an updated refractive prescription and will wear them for 35 ± 5 days. Symptoms will be reassessed after the 35-day control break in. If the subject's symptoms have subsided, they will be exited from the study and will keep their lenses. Provided the subject has symptoms (HIT questionnaire score ≥ 56) after their 35-day use of their updated prescription and they continue to meet the inclusion/exclusion criteria they will proceed to the evaluation portion of the protocol. The first arm receiving neurolens first and the second arm receiving the control first. The control is a single vision or PAL lens which yields the BCDVA and BCNVA of a test subject with no prismatic correction. The neurolens prescribed prism will be based on the practitioner's Rx using the subject's best response to a prism trial lens and must be within a half prism diopter of the neurolens value output of the neurolens Measurement Device and providing the subject's BCDVA and BCNVA. Participants will come back after 35 day wear of their first test lens and the symptom questionnaire is reassessed. They will be now be crossed over to the second pair of study lenses (i.e. subjects in the first arm will not receive control lens and the ones in the second arm will not receive neurolens). Participants will come back after 35 day wear of their second test lens and the symptom questionnaire is reassessed for the final time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective randomized double masked two arm
| Arm | Type | Receives |
|---|---|---|
| Neurolens | Experimental | Device: Neurolens spectacle lensOur proprietary contoured prism lens design, commercially known as neurolens. |
| Control lens | Placebo comparator | Device: Placebo spectacle lensA simple refractive error correction lens |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female, and between 18-60 years of age at the time of signing the informed consent.
- Best Corrected distance and near acuity are equal to or better than 20/25 Snellen Equivalent in each eye.
- Best Corrected distance and near binocular acuity are equal to or better than 20/25 Snellen Equivalent.
- Symptomatic as indicated by the HIT-6 questionnaire (Score equal to or greater than 56)
- Updated distance spectacle prescription must match the following
Key exclusion criteria (20 listed)
- Subjects who need a vertical prism.
- Previously has worn neurolenses.
- Subjects who need a near add less than 1.00D
- Use of contact lenses during the study
- Lack of binocular vision, including strabismus, amblyopia, or suppression.
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 |
|---|---|---|
| Neurolens spectacle lensspectacle lens | Device | Neurolens |
| Placebo spectacle lensspectacle lens for refractive error correction | Device | Control lens |
Primary outcome
Headache Impact Test (HIT-6) questionnaire
Time frame: 30-40 days
Change in headache impact test (HIT-6) with the use of neurolenses compared to control lenses. The minimum response score for each question is 6 and the maximum is 13. Larger scores would indicate a more symptomatic patient. Larger difference in the cumulative response score between treatment visit and the baseline visit would indicate a greater impact of the treatment.
1 secondary outcome
Patients with reduced near point of convergence (NPC)
Time frame: 30-40 days
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 12 Oct 2023.
- Individual participant dataSharing planned: Yes. We will be providing a backend read-only excel spreadsheet of the raw data that was entered on the digital data platform provided to the clinical site.
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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.
Corina Van De Pol, OD PhD study director
Neurolens Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurolens spectacle lens in people with Binocular Vision Disorder and Convergence Insufficiency, run by Neurolens Inc. at 10 sites 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 11 inclusion and 20 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. Some participants in this study may receive a placebo. 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?
Headache Impact Test (HIT-6) questionnaire (time frame: 30-40 days). 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 12 Oct 2023.