NCT02279446

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

Same day

First QC Date

October 13, 2014

Last Update Submit

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.

Other: Intermediate Visual acuity (IVA) assessment

20/20D group

This group will have 20/20 distant visual acuity and variable near visual acuity.

Other: Intermediate Visual acuity (IVA) assessment

20/20N group

This group will have 20/20 near visual acuity and variable distant visual acuity.

Other: Intermediate Visual acuity (IVA) assessment

s20/20ND group

This group will have variable near and distant visual acuity (both less than 20/20)

Other: Intermediate Visual acuity (IVA) assessment

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

20/20D group20/20N group20/20ND groups20/20ND group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

MyopiaHyperopiaPresbyopiaAstigmatism

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Georgios Labiris, MD, PhD

    Assistant Professor

    STUDY DIRECTOR

Central Study Contacts

Georgios Labiris, MD, PhD

CONTACT

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

Locations