Neurolens Headache Study

NCT05070767 | Completed FDA Device

• 1 other identifier: NLR - 210720
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30-40 days

Secondary Outcomes (1)

• Patients with reduced near point of convergence (NPC)

  30-40 days

Study Arms (2)

Neurolens

EXPERIMENTAL

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

Device: Neurolens spectacle lens

Control lens

PLACEBO COMPARATOR

A simple refractive error correction lens

Device: Placebo spectacle lens

Interventions

Neurolens spectacle lens DEVICE

spectacle lens

Neurolens

Placebo spectacle lens DEVICE

spectacle lens for refractive error correction

Control lens

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurolens Inc.: lead

Study Sites (10)

Advanced Vision and Achievement Center

Phoenix, Arizona, 85051, United States

Location

The Eye Center

Conyers, Georgia, 30012, United States

Location

Advanced Eyecare Center

Perry, Georgia, 31069, United States

Location

Eyecare of Rigby

Rigby, Idaho, 83442, United States

Location

Signature Eye Care

Lincoln, Nebraska, 68516, United States

Location

Buckeye Family Eye Clinic

Hillsboro, Ohio, 45133, United States

Location

Preferred Eye Care Center

Mt. Pleasant, South Carolina, 29466, United States

Location

Kapperman White and McGarvey

Chattanooga, Tennessee, 37421, United States

Location

Springhill Eye Care

Spring Hill, Tennessee, 37174, United States

Location

Eyes for Life

Spokane, Washington, 99203, United States

Location

MeSH Terms

Conditions

Ocular Motility Disorders; Headache

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Corina Van De Pol, OD PhD

  Neurolens Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Prospective randomized double masked two arm
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective randomized double masked two arm

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: October 18, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available along with the publication for at least 5 years.
• Access Criteria: On request

Locations

US (10)