Neurolens Convergence Insufficiency Study

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05087563
Study type	Interventional
Source	Neurolens Inc.
Contact
Status	Terminated
Phase	N/A
Start date	November 22, 2021
Completion date	May 31, 2022

View Details

See also
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.