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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.