Neurolens Headache Study (NCT05070767) | Clinical Trial Compass
CompletedNot Applicable
Neurolens Headache Study
United States300 participantsStarted 2021-10-18
Plain-language 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).
Who can participate
Age range18 Years – 60 Years
SexALL
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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,…