Development of a Validated Chart for Intermediate Vision Assessment

Sponsor
Democritus University of Thrace (Other)
Overall Status
Unknown status
CT.gov ID
NCT02279446
Collaborator
(none)
400
1
6
66.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Time Perspective:
Cross-Sectional
Official Title:
Development of a Validated Chart for Intermediate Vision Assessment
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Oct 1, 2014
Anticipated Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Intermediate Visual Acuity (IVA) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Institute Of thrace Alexandroupolis Evros Greece 68100

Sponsors and Collaborators

  • Democritus University of Thrace

Investigators

  • Study Director: Georgios Labiris, MD, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Georgios Labiris, Assistant Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT02279446
Other Study ID Numbers:
  • 263/13-10-2014
First Posted:
Oct 31, 2014
Last Update Posted:
Oct 31, 2014
Last Verified:
Oct 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2014