Development of a Validated Chart for Intermediate Vision Assessment

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

Study Overview

• Status: Unknown
• Conditions: Presbyopia; Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Georgios Labiris, MD, PhD; Phone Number: 00302551039891; Email: labiris@usa.net

Study Locations

• Greece
  • Evros
    • Alexandroupolis, Evros, Greece, 68100
      • Recruiting
      • Eye Institute Of thrace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Random

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermediate Visual Acuity (IVA)	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)	6 months

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Study Director: Georgios Labiris, MD, PhD, Assistant professor

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 29, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Astigmatism; Hyperopia
• Other Study ID Numbers: 263/13-10-2014