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Neurolens Convergence Insufficiency Study

NCT05087563 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-13

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 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).

Conditions

  • Binocular Vision Disorder
  • Convergence Insufficiency
  • Computer Vision Syndrome

Interventions

DEVICE

Neurolens spectacle lens

spectacle lens

DEVICE

Placebo spectacle lens

spectacle lens for refractive 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
2021-11-22
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05087563 on ClinicalTrials.gov