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CompletedNCT05070767Updated Oct 12, 2023

Neurolens Headache Study

An interventional study of Neurolens spectacle lens and Placebo spectacle lens in Binocular Vision Disorder, Convergence Insufficiency and Headache, sponsored by Neurolens Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Neurolens Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2022, 4 years 4 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Binocular Vision Disorder
  • Convergence Insufficiency
  • Headache
  • Computer Vision Syndrome

Keywords

  • headache
  • neurolenses
  • computer vision syndrome
  • convergence insufficiency
  • binocular vision
  • non-strabismic disorder
  • Digital vision syndrome
03

In context

Ocular Motility Disorders

54 studies on the registry are indexed under Ocular Motility Disorders; 19 are open to participants now.

This study's enrollment of 300 is above the median of 91 across 38 interventional studies indexed under Ocular Motility Disorders.

Browse Ocular Motility Disorders studies →

Lead sponsor

Neurolens Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

    a. 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

  • Subjects' eye alignment tests must match the following:

    a. 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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."
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Neurolens

    Our proprietary contoured prism lens design, commercially known as neurolens.

    Device: Neurolens spectacle lens

  • Placebo comparator
    Control lens

    A simple refractive error correction lens

    Device: Placebo spectacle lens

Interventions

  • DeviceNeurolens spectacle lens

    spectacle lens

  • DevicePlacebo spectacle lens

    spectacle lens for refractive error correction

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 30-40 days

07

Study locations

10 sites
  • Advanced Vision and Achievement Center
    Phoenix, Arizona 85051, United States
  • The Eye Center
    Conyers, Georgia 30012, United States
  • Advanced Eyecare Center
    Perry, Georgia 31069, United States
  • Eyecare of Rigby
    Rigby, Idaho 83442, United States
  • Signature Eye Care
    Lincoln, Nebraska 68516, United States
  • Buckeye Family Eye Clinic
    Hillsboro, Ohio 45133, United States
  • Preferred Eye Care Center
    Mount Pleasant, South Carolina 29466, United States
  • Kapperman White and McGarvey
    Chattanooga, Tennessee 37421, United States
  • Springhill Eye Care
    Spring Hill, Tennessee 37174, United States
  • Eyes for Life
    Spokane, Washington 99203, United States
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05070767
Lead sponsor
Neurolens Inc.
Responsible party
Sponsor
First posted
Oct 7, 2021
Start date
Oct 18, 2021
Primary completion
May 30, 2022
Completion
May 30, 2022
Last update
Oct 12, 2023

Study contacts

Corina Van De Pol, OD PhD
study director · Neurolens Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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