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
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).
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.
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 →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.
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)
Exclusion Criteria:
Our proprietary contoured prism lens design, commercially known as neurolens.
Device: Neurolens spectacle lens
A simple refractive error correction lens
Device: Placebo spectacle lens
spectacle lens
spectacle lens for refractive error correction
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
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
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.
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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Neurolens Inc.