Convergence Insufficiency Clinical Trial
Official title:
Randomized Controlled Double Masked Two Arm Cross-over Study of Neurolenses in Subjects With Convergence Insufficiency
Verified date | October 2023 |
Source | Neurolens Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 50 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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." |
Country | Name | City | State |
---|---|---|---|
United States | Brea Optometry | Brea | California |
United States | Fort Collins Family Eye Care | Fort Collins | Colorado |
United States | Gaddie Eye Centers | Louisville | Kentucky |
United States | Total Vision Eyecare | Manchester | Connecticut |
United States | Suarez Optical | Miami | Florida |
United States | South Waterfront Eye Care | Portland | Oregon |
United States | Rock River Eye Care | Rock Rapids | Iowa |
United States | Eyes and Ears | Southlake | Texas |
United States | Clarke EyeCare Center | Wichita Falls | Texas |
Lead Sponsor | Collaborator |
---|---|
Neurolens Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
30-40 days | |
Secondary | 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 |
30-40 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03248336 -
Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in Children
|
N/A | |
Recruiting |
NCT05262361 -
Persistent Post-Concussion Symptoms With Convergence Insufficiency
|
N/A | |
Terminated |
NCT03123822 -
Spectacles Lens in Concussed Kids
|
N/A | |
Completed |
NCT00472407 -
Screening for Convergence Insufficiency in School-age Children
|
||
Completed |
NCT00347945 -
Randomized Trial of Treatments for Convergence Insufficiency
|
Phase 3 | |
Completed |
NCT05070767 -
Neurolens Headache Study
|
N/A | |
Completed |
NCT03319966 -
Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
|
||
Recruiting |
NCT04691427 -
Effectiveness of Virtual Reality Vision Therapy - VERVE
|
Early Phase 1 | |
Completed |
NCT02607384 -
The Baltimore Reading and Eye Disease Study
|
N/A | |
Active, not recruiting |
NCT02207517 -
Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency
|
Phase 3 | |
Completed |
NCT00347581 -
A Randomized Trial of Base-in Prism Reading Glasses Convergence Insufficiency in Children
|
Phase 3 | |
Recruiting |
NCT05603962 -
The Effectiveness of Visual Training in Convergence Insufficiency Patients
|
N/A | |
Completed |
NCT01515943 -
Convergence Insufficiency Treatment Study (CITS)
|
N/A | |
Recruiting |
NCT05877560 -
Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency
|
N/A | |
Recruiting |
NCT05948046 -
The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency
|
||
Active, not recruiting |
NCT00338611 -
Convergence Insufficiency Treatment Trial (CITT)
|
Phase 3 | |
Recruiting |
NCT05012384 -
Effect of Vergence Exercises for Patients With Convergence Insufficiency After Concussion.
|
N/A | |
Recruiting |
NCT05761106 -
Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders
|
N/A | |
Completed |
NCT02510040 -
A Prospective Observational Study of Adult Strabismus
|
||
Recruiting |
NCT05311917 -
Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency
|
N/A |