NCT02862405

Brief Summary

The loss of central vision causes difficulty not only in reading but also in faces recognition, and in particular in the identification of facial expression, objects or spaces. These visual deficits have been mainly studied in relation with reading, which is the main complaint of these kind of patients. However, there are not enough data regarding perception of objects and spaces in this population. Then, the objectives are to study the visual-spatial abilities in individuals with vision loss, and altered cognitive processes, (2) to develop clinics tools for early detection and quantification of visual-spatial deficits and (3)to understand the capacities of normal peripheral vision in order to test the possibility of potential training for use of peripheral vision when central vision is impaired by an ophthalmic pathology.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

August 2, 2016

Last Update Submit

August 8, 2016

Conditions

Vision Loss

Keywords

Vision lossObject recognitionSpace recognition

Outcome Measures

Primary Outcomes (2)

  • Comparison of performances in visual tests between different groups according to error rate

    These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.

    at inclusion

  • Comparison of performances in visual tests between different groups according to answer time

    These behavioral studies include a series of short tests of 5 to 10 minutes each (not exceeding 60 minutes with breaks and instructions) in which photos of scenes or isolated objects will be presented in central or peripheral vision using a computer screen or a panoramic screen covering a 180° field.

    at inclusion

Secondary Outcomes (3)

  • Estimation of the score of visual acuity by the logMAR chart

    at inclusion

  • Measure of lesion size

    at inclusion

  • Pearson correlation coefficient to determine the correlation between the performance parameters during visual tests (error rate and answer time) and clinical parameters (visual acuity and lesion size)

    at inclusion

Study Arms (3)

Patients with loss of central vision

Patients coming in ophthalmic consultation will be selected for the study. The diagnosis of this disease is based on clinical examination, and imaging of the retina.Patients with only loss of central vision will be selected.

Other: vision tests

Patients with loss of peripheral vision

Patients coming in ophthalmic consultation will be selected for the study. Patients with loss of peripheral vision will be selected on the bases of presence of tunnel vision.

Other: vision tests

Control group

Patients without loss of vision.

Other: vision tests

Interventions

vision testsOTHER
Control groupPatients with loss of central visionPatients with loss of peripheral vision

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with eye disease causing loss of central or peripheral vision

You may qualify if:

  • Patients with eye disease causing loss of central or peripheral vision
  • French speakers
  • Age between 18 and 90 years old
  • Written consent
  • Health insurance
  • Sex and age matched controls (+/- 5 years)
  • French speakers
  • Normal visual examination with visual acuity of min 9/10

You may not qualify if:

  • Psychiatric disease or neurological pathologies
  • Communication difficulties (deafness / mutism)
  • Drug treatment altering concentration
  • Mental deterioration with MMS \<24
  • Alcoholism or addiction to drugs
  • Persons under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thi Ha Chau Tran, MD

    Hospital of the Lille Catholic Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 11, 2016

Study Start

March 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 11, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share