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Development of a Validated Chart for Intermediate Vision Assessment

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ClinicalTrials.gov Identifier: NCT02279446
Recruitment Status : Unknown
Verified October 2014 by Georgios Labiris, Democritus University of Thrace.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace

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

Condition or disease Intervention/treatment
Myopia Hyperopia Presbyopia Astigmatism Other: Intermediate Visual acuity (IVA) assessment

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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Time Perspective: Cross-Sectional
Official Title: Development of a Validated Chart for Intermediate Vision Assessment
Study Start Date : October 2014
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : April 2015

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Group/Cohort Intervention/treatment
20/20ND group
This group will have 20/20 visual acuity both in distant and near.
Other: Intermediate Visual acuity (IVA) assessment
Intermediate visual acuity (IVA) will be assessed with the Intermediate Visual acuity chart which 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

20/20D group
This group will have 20/20 distant visual acuity and variable near visual acuity.
Other: Intermediate Visual acuity (IVA) assessment
Intermediate visual acuity (IVA) will be assessed with the Intermediate Visual acuity chart which 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

20/20N group
This group will have 20/20 near visual acuity and variable distant visual acuity.
Other: Intermediate Visual acuity (IVA) assessment
Intermediate visual acuity (IVA) will be assessed with the Intermediate Visual acuity chart which 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

s20/20ND group
This group will have variable near and distant visual acuity (both less than 20/20)
Other: Intermediate Visual acuity (IVA) assessment
Intermediate visual acuity (IVA) will be assessed with the Intermediate Visual acuity chart which 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




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Random
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279446


Contacts
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Contact: Georgios Labiris, MD, PhD 00302551039891 labiris@usa.net

Locations
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Greece
Eye Institute Of thrace Recruiting
Alexandroupolis, Evros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
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Study Director: Georgios Labiris, MD, PhD Assistant Professor

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Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT02279446     History of Changes
Other Study ID Numbers: 263/13-10-2014
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Astigmatism
Presbyopia
Hyperopia
Refractive Errors
Eye Diseases