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Neurolens Headache Study

Primary Purpose

Binocular Vision Disorder, Convergence Insufficiency, Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurolens spectacle lens
Placebo spectacle lens
Sponsored by
Neurolens Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

Neurolens

Control lens

Arm Description

Our proprietary contoured prism lens design, commercially known as neurolens.

A simple refractive error correction lens

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 27, 2021
Last Updated
October 11, 2023
Sponsor
Neurolens Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05070767
Brief Title
Neurolens Headache Study
Official Title
Randomized Controlled Double Masked Two Arm Cross-over Study of Neurolenses in Subjects With Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurolens Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binocular Vision Disorder, Convergence Insufficiency, Headache, Computer Vision Syndrome
Keywords
headache, neurolenses, computer vision syndrome, convergence insufficiency, binocular vision, non-strabismic disorder, Digital vision syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective randomized double masked two arm
Masking
ParticipantCare ProviderInvestigator
Masking Description
Prospective randomized double masked two arm
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurolens
Arm Type
Experimental
Arm Description
Our proprietary contoured prism lens design, commercially known as neurolens.
Arm Title
Control lens
Arm Type
Placebo Comparator
Arm Description
A simple refractive error correction lens
Intervention Type
Device
Intervention Name(s)
Neurolens spectacle lens
Intervention Description
spectacle lens
Intervention Type
Device
Intervention Name(s)
Placebo spectacle lens
Intervention Description
spectacle lens for refractive error correction
Primary Outcome Measure Information:
Title
Headache Impact Test (HIT-6) questionnaire
Description
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
Secondary Outcome Measure Information:
Title
Patients with reduced near point of convergence (NPC)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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."
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corina Van De Pol, OD PhD
Organizational Affiliation
Neurolens Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Vision and Achievement Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Facility Name
The Eye Center
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30012
Country
United States
Facility Name
Advanced Eyecare Center
City
Perry
State/Province
Georgia
ZIP/Postal Code
31069
Country
United States
Facility Name
Eyecare of Rigby
City
Rigby
State/Province
Idaho
ZIP/Postal Code
83442
Country
United States
Facility Name
Signature Eye Care
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Buckeye Family Eye Clinic
City
Hillsboro
State/Province
Ohio
ZIP/Postal Code
45133
Country
United States
Facility Name
Preferred Eye Care Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29466
Country
United States
Facility Name
Kapperman White and McGarvey
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Springhill Eye Care
City
Spring Hill
State/Province
Tennessee
ZIP/Postal Code
37174
Country
United States
Facility Name
Eyes for Life
City
Spokane
State/Province
Washington
ZIP/Postal Code
99203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available along with the publication for at least 5 years.
IPD Sharing Access Criteria
On request

Learn more about this trial

Neurolens Headache Study

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