Neurolens Headache Study

Completed · Not applicable · Has a placebo group

Conditions studied: Binocular Vision Disorder, Convergence Insufficiency, Headache, Computer Vision Syndrome

In brief

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).

Key facts

Study ID

NCT05070767

Run by

Neurolens Inc.

People needed

300

Starts

2021-10-18

Expected to finish

2022-05-30

Last updated by the study team

2023-10-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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."

Where it is running

• Advanced Vision and Achievement Center — Phoenix, Arizona, United States
• The Eye Center — Conyers, Georgia, United States
• Advanced Eyecare Center — Perry, Georgia, United States
• Eyecare of Rigby — Rigby, Idaho, United States
• Signature Eye Care — Lincoln, Nebraska, United States
• Buckeye Family Eye Clinic — Hillsboro, Ohio, United States
• Preferred Eye Care Center — Mt. Pleasant, South Carolina, United States
• Kapperman White and McGarvey — Chattanooga, Tennessee, United States
• Springhill Eye Care — Spring Hill, Tennessee, United States
• Eyes for Life — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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