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Clinical Trials/NCT02279446
NCT02279446
Unknown
Not Applicable

Development of a Validated Chart for Intermediate Vision Assessment

Democritus University of Thrace1 site in 1 country400 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Democritus University of Thrace
Enrollment
400
Locations
1
Primary Endpoint
Intermediate Visual Acuity (IVA)
Last Updated
11 years ago

Overview

Brief Summary

Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.

Detailed Description

Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity (IVA). It is known that no validated method for the evaluation of IVA exists. Primary objective of the study is to validate a specific computer-based chart (optotype) that will enable: a) comparative studies among different groups of presbyopic patients with refractive errors (ie. myopia, hyperopia, and/or astigmatism), and, b) assessment of the efficacy of surgical refractive procedures (ie. LASIK) on presbyopic patients. Intermediate Visual acuity chart is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5 Validation of the computer-based IVA chart will be done by correlating the results of the IVA chart to the corresponding ones from the validated 20/20 distant and Jaeger near visual acuity charts, in a random sample of study participants with different refractive errors and different near and distant visual acuities.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
April 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Georgios Labiris

Assistant Professor

Democritus University of Thrace

Eligibility Criteria

Inclusion Criteria

  • native Greek participants or foreigners with perfect knowledge (verbal and written) of Greek language

Exclusion Criteria

  • glaucoma or suspicion for glaucoma,
  • corneal disease or suspicion for corneal disease
  • fundus disease or suspicion for fundus disease
  • pregnancy or nursing,
  • underlying autoimmune disease
  • mental or neurologic disease

Outcomes

Primary Outcomes

Intermediate Visual Acuity (IVA)

Time Frame: 6 months

Number of participants that their intermediate visual acuity measured with the "intermediate visual acuity chart" will be statistically correlated with distant visual acuity (measured by 20/20 chart) and near visual acuity (measured by Jaeger chart)

Study Sites (1)

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