Vision Measured by the Vimetrics CVA Compared With Chart Testing Under Similar Luminance and Contrast Conditions

NCT02028351 | Completed DMC

• 1 other identifier: VVS 001
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief Summary

Purpose of The Study: The purpose of this study is the following: A)To gather age-related normative visual acuity data for the Vimetrics Central Vision Analyzer (CVA, Vimetrics, LLC, Media, Pa) B)To gather visual acuity data for patients with known ocular problems, including cataract and maculopathy. C)To correlate and compare the CVA visual acuity findings with the acuity measured with standard LogMAR acuity charts viewed under similar conditions of contrast and lighting

Conditions

Refractive Error; Cataract; Maculopathy

Keywords

visual acuity; contrast sensitivity; cataract; maculopathy

Outcome Measures

Primary Outcomes (1)

• Measurement of monocular Visual Acuity

  Upon recruitment

Study Arms (3)

Normal

No Intervention

Cataract

No intervention

Maculopathy

No Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Eye Clinic

You may not qualify if:

• those individuals whom the examiner determines cannot read the ETDRS letter chart to define vision and those individuals whom the examiner determines cannot respond to the computer presentation of the tumbled Landolt C by pressing one of the 4 buttons arranged in a diamond or by deflecting the joystick on the response pad held in the lap.
• Normals:
• A visual acuity measured of 20/30 or better for which on examination the refractive error alone is determined to define the vision.
• For individuals 65 years or greater, lens nuclear opalescence and brunescence that is less than or equal to NO3, NC3 according to the LOCS III grading system.
• For individuals less than 65 years, lens nuclear opalescence and brunescence that is less than or equal to NO2, NC2, according to the LOCS III grading system.
• Media opacity or retinal or optic nerve pathology that the examiner determines would affect the measured vision.
• For individuals aged 65 or greater, eyes with nuclear opalescence and brunescence, according to the LOCS III grading system greater than NO3, NC3 or with other opacities will be excluded.
• Eyes with Cataracts:
• Persons without systemic disease that would interfere with vision will be enrolled. Such diseases that would exclude a subject from this category would include diabetes, and other systemic diseases such as neurological disorders that the examiner determines may interfere with the vision of an eye.
• A visual acuity worse than 20/30. The determination on examination by the examiner that the lens opacity alone defines the vision. For individuals less than age 65 the nuclear cataract will be denser than NO2, NC2 or contain other components (posterior cortical or posterior sub capsular) that will be documented. For individuals 65 years of age or older, the nuclear cataract will be greater than NO3, NC3 or contain other components that define the vision.
• Eyes in which retinal or optic nerve pathology that the examiner determines would affect the measured vision.
• Eyes with a best refracted chart acuity of 20/100 or worse because in such eyes the examiner will be prevented by the media opacity from adequately examining the fundus to determine if there is co-existent macular pathology.
• Eyes with Maculopathy:
• It is recognized that many individuals within this group will have diabetes or hypertension that may be the cause of the maculopathy or aggravate the maculopathy. However, such systemic diseases will not necessarily exclude such persons, unless the examiner determines that such diseases cause reduced vision in the eye that is not defined by the maculopathy.
• A visual acuity with chart testing worse than 20/30 for which on examination the maculopathy alone is determined to define the vision.

Sponsors & Collaborators

• Sinclair Technologies, LLC: lead

Study Sites (2)

Pennsylvania College of Optometry

Elkins Park, Pennsylvania, 19027, United States

Location

Gutstein Optik

Vienna, Austria

Location

Related Publications (6)

• Arditi A, Cagenello R. On the statistical reliability of letter-chart visual acuity measurements. Invest Ophthalmol Vis Sci. 1993 Jan;34(1):120-9.

  PMID: 8425819 BACKGROUND

• Bourne RR, Rosser DA, Sukudom P, Dineen B, Laidlaw DA, Johnson GJ, Murdoch IE. Evaluating a new logMAR chart designed to improve visual acuity assessment in population-based surveys. Eye (Lond). 2003 Aug;17(6):754-8. doi: 10.1038/sj.eye.6700500.

  PMID: 12928690 BACKGROUND

• Hazel CA, Elliott DB. The dependency of logMAR visual acuity measurements on chart design and scoring rule. Optom Vis Sci. 2002 Dec;79(12):788-92. doi: 10.1097/00006324-200212000-00011.

  PMID: 12512687 BACKGROUND

• Raasch TW, Bailey IL, Bullimore MA. Repeatability of visual acuity measurement. Optom Vis Sci. 1998 May;75(5):342-8. doi: 10.1097/00006324-199805000-00024.

  PMID: 9624699 BACKGROUND

• Bailey IL. New procedures for detecting early vision losses in the elderly. Optom Vis Sci. 1993 Apr;70(4):299-305. doi: 10.1097/00006324-199304000-00008.

  PMID: 8502458 BACKGROUND

• Carkeet A. Modeling logMAR visual acuity scores: effects of termination rules and alternative forced-choice options. Optom Vis Sci. 2001 Jul;78(7):529-38. doi: 10.1097/00006324-200107000-00017.

  PMID: 11503943 BACKGROUND

MeSH Terms

Conditions

Refractive Errors; Cataract; Macular Degeneration

Condition Hierarchy (Ancestors)

Eye Diseases; Lens Diseases; Retinal Degeneration; Retinal Diseases

Study Officials

• Stephen H Sinclair, MD

  Sinclair Technologies, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: December 29, 2012
• First Posted: January 7, 2014
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

AU (1); US (1)