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Neurolens Headache Study

NCT05070767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-12

No results posted yet for this study

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

Interventions

DEVICE

Neurolens spectacle lens

spectacle lens

DEVICE

Placebo spectacle lens

spectacle lens for refractive error correction

Sponsors & Collaborators

  • Neurolens Inc.

    lead INDUSTRY

Principal Investigators

  • Corina Van De Pol, OD PhD · Neurolens Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2022-05-30
Completion
2022-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05070767 on ClinicalTrials.gov