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Neurolens Convergence Insufficiency Study

Primary Purpose

Binocular Vision Disorder, Convergence Insufficiency, Computer Vision Syndrome

Status
Terminated
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 convergence insufficiency, neurolenses, computer vision syndrome, binocular vision, non-strabismic disorder, digital vision syndrome, headache

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 CISS questionnaire (Score equal to or greater than 16)

  • Updated distance spectacle prescription must match the following

    1. Spherical power inclusive between +4.00D to -8.00D
    2. Cylinder power no more than -4.00Dcyl
    3. ADD power i. Subgroup 1: No ADD ii. Subgroup2: 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)

  • Near point of convergence greater than or equal to 5cms
  • 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

  • Brea Optometry
  • Fort Collins Family Eye Care
  • Total Vision Eyecare
  • Suarez Optical
  • Rock River Eye Care
  • Gaddie Eye Centers
  • South Waterfront Eye Care
  • Eyes and Ears
  • Clarke EyeCare Center

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

Convergence Insufficiency Symptom Score (CISS) questionnaire
Change in Convergence Insufficiency Symptom Score (CISS) with the use of neurolenses compared to control lenses. The minimum response score for each question is 0 and the maximum score is 4. A larger score would indicate a more symptomatic patient Large difference in the cumulative symptom score between the treatment visit and baseline visit would indicate a more effective treatment

Secondary Outcome Measures

Patients with Good Stereoacuity
Change in the Convergence Insufficiency Symptom Score (CISS) score with the use of neurolens compared to control lenses in subjects with good stereoacuity. The minimum response score for each question is 0 and the maximum score is 4. A larger score would indicate a more symptomatic patient Large difference in the cumulative symptom score between the treatment visit and baseline visit would indicate a more effective treatment

Full Information

First Posted
October 8, 2021
Last Updated
October 11, 2023
Sponsor
Neurolens Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05087563
Brief Title
Neurolens Convergence Insufficiency Study
Official Title
Randomized Controlled Double Masked Two Arm Cross-over Study of Neurolenses in Subjects With Convergence Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
New evidence warranted a change in the study design and study population group (inclusion/ exclusion criterion). We completed another clinical trial focused on subjects with headache symptoms but this particular clinical trial was terminated.
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 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 Convergence Insufficiency. It is a Prospective randomized double masked two arm performed on a minimum of 100 to a maximum of 150 subjects identified as symptomatic (CISS questionnaire score equal to or greater than 16) done across 3-10 clinical sites. There are two subgroups: a minimum of 50 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 convergence insufficiency symptoms (convergence insufficiency symptom score (CISS v-15) 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 (CISS questionnaire score ≥ 16) 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, Computer Vision Syndrome
Keywords
convergence insufficiency, neurolenses, computer vision syndrome, binocular vision, non-strabismic disorder, digital vision syndrome, headache

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
50 (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 correction
Primary Outcome Measure Information:
Title
Convergence Insufficiency Symptom Score (CISS) questionnaire
Description
Change in Convergence Insufficiency Symptom Score (CISS) with the use of neurolenses compared to control lenses. The minimum response score for each question is 0 and the maximum score is 4. A larger score would indicate a more symptomatic patient Large difference in the cumulative symptom score between the treatment visit and baseline visit would indicate a more effective treatment
Time Frame
30-40 days
Secondary Outcome Measure Information:
Title
Patients with Good Stereoacuity
Description
Change in the Convergence Insufficiency Symptom Score (CISS) score with the use of neurolens compared to control lenses in subjects with good stereoacuity. The minimum response score for each question is 0 and the maximum score is 4. A larger score would indicate a more symptomatic patient Large difference in the cumulative symptom score between the treatment visit and baseline visit would indicate a more effective 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 CISS questionnaire (Score equal to or greater than 16) Updated distance spectacle prescription must match the following Spherical power inclusive between +4.00D to -8.00D Cylinder power no more than -4.00Dcyl ADD power i. Subgroup 1: No ADD ii. Subgroup2: 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) Near point of convergence greater than or equal to 5cms 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
Brea Optometry
City
Brea
State/Province
California
ZIP/Postal Code
92821
Country
United States
Facility Name
Fort Collins Family Eye Care
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80526
Country
United States
Facility Name
Total Vision Eyecare
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Suarez Optical
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Rock River Eye Care
City
Rock Rapids
State/Province
Iowa
ZIP/Postal Code
51246
Country
United States
Facility Name
Gaddie Eye Centers
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
South Waterfront Eye Care
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Eyes and Ears
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Clarke EyeCare Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76308
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 Convergence Insufficiency Study

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