Development of a Validated Chart for Intermediate Vision Assessment

Myopia Clinical Trial

Official title:

Development of a Validated Chart for Intermediate Vision Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02279446
• Other study ID #: 263/13-10-2014
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2014
• Last updated: October 29, 2014
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2014
• Source: Democritus University of Thrace
• Contact: Georgios Labiris, MD, PhD
• Phone: 00302551039891
• Email: labiris[@]usa.net
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia
• Presbyopia

Intervention

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

Locations

Country	Name	City	State
Greece	Eye Institute Of thrace	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No