Clinical Trials Logo
  1. Home
  2. Myopia
  3. NCT04208750
  4. Details
NCT04208750 Clinical Trial

Clinical Investigation of the Vision-R800 Device.

Myopia Clinical Trial

Official title:
Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04208750
Other study ID # Kollbaum003
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 18, 2019
Est. completion date February 1, 2021

Study information
Verified date February 2022
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - current adaptated progressive addition lens wearer, if bifocal lens required - wearable pair of glasses < 2 years old - wear glasses at least 6 hours per day Exclusion Criteria: - Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report) - Formal training in optometry, vision science or in the eyecare field

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Vision R-800 Phoropter
Refraction utilizing the Vision R-800 Phoropter with resulting glasses
• Standard Phoropter
Refraction utilizing the standard phoropter with resulting glasses

Locations
Country Name City State
United States Indiana University Clinical Optics Research Lab Bloomington Indiana

Sponsors (1)
Lead Sponsor Collaborator
Pete Kollbaum, OD, PhD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective Questionnaire Response Patient questions of refraction preference for quickness, efficiency, comfort, and stress at Visit 5 (final visit), up to 5 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04923841 - Myopia Control Using Bright Light Therapy, Myopic Defocus and Atropine N/A
Active, not recruiting NCT04080128 - Examination of Myopia Progression and Soft Bifocal Contact Lens Myopia Control N/A
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Completed NCT04604405 - Effects of 650nm Low Energy Light on Human Retina and Choroid Microcirculation N/A
Recruiting NCT05594719 - The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow N/A
Completed NCT05594732 - The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow N/A
Completed NCT04492397 - Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI) N/A
Completed NCT04536571 - Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses N/A
Completed NCT06046209 - Comparing a Monthly Replacement Lens Versus a Daily Disposable Lens N/A
Recruiting NCT06344572 - Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia Phase 3
Recruiting NCT05611294 - Contralateral Study of Topography Guided LASIK Versus Small Incision Lenticule Extraction N/A
Completed NCT05656885 - Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses N/A
Active, not recruiting NCT05534022 - Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression. N/A
Completed NCT03934788 - the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT03701516 - Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2 N/A
Completed NCT05538754 - Post-Market Evaluation of the EVO ICL N/A
Completed NCT03139201 - Clinical Performance of the OxyAqua Daily Disposable Silicone Hydrogel Soft Contact Lens N/A
Completed NCT02555722 - Evaluation of the CooperVision, Inc. Fanfilcon A and Enfilcon A Daily Wear Contact Lenses When Used for Frequent Replacement for up to One (1) Month of Daily Wear N/A
Not yet recruiting NCT06009458 - Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear N/A
Recruiting NCT05548478 - Corneal Endothelial Cell Injury Induced by Mitomycin-C N/A