Development of a Validated Chart for Intermediate Vision Assessment
1 other identifier
observational
400
1 country
1
Brief Summary
Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 13, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedOctober 31, 2014
October 1, 2014
Same day
October 13, 2014
October 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
20/20ND group
This group will have 20/20 visual acuity both in distant and near.
20/20D group
This group will have 20/20 distant visual acuity and variable near visual acuity.
20/20N group
This group will have 20/20 near visual acuity and variable distant visual acuity.
s20/20ND group
This group will have variable near and distant visual acuity (both less than 20/20)
Interventions
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
Eligibility Criteria
Random
You may qualify if:
- native Greek participants or foreigners with perfect knowledge (verbal and written) of Greek language
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye Institute Of thrace
Alexandroupoli, Evros, 68100, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Georgios Labiris, MD, PhD
Assistant Professor
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 13, 2014
First Posted
October 31, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2014
Study Completion
April 1, 2015
Last Updated
October 31, 2014
Record last verified: 2014-10