Neurolens Headache Study
Binocular Vision Disorder, Convergence Insufficiency, Headache
About this trial
This is an interventional treatment trial for Binocular Vision Disorder focused on measuring headache, neurolenses, computer vision syndrome, convergence insufficiency, binocular vision, non-strabismic disorder, Digital vision syndrome
Eligibility Criteria
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:
- 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."
Sites / Locations
- Advanced Vision and Achievement Center
- The Eye Center
- Advanced Eyecare Center
- Eyecare of Rigby
- Signature Eye Care
- Buckeye Family Eye Clinic
- Preferred Eye Care Center
- Kapperman White and McGarvey
- Springhill Eye Care
- Eyes for Life
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Neurolens
Control lens
Our proprietary contoured prism lens design, commercially known as neurolens.
A simple refractive error correction lens