Perception of Objects and Natural Scenes in People With Vision Loss (ACTIVIS)

Vision Loss Clinical Trial

— ACTIVIS  

Official title:

Evaluation of the Perception of Objects and Natural Scenes in People With Vision Loss (Loss of Central or Peripheral Vision)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862405
• Other study ID #: RC-P009
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 8, 2016
• Start date: March 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2016
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria cases:

• Patients with eye disease causing loss of central or peripheral vision

• French speakers

• Age between 18 and 90 years old

• Written consent

• Health insurance

Inclusion Criteria controls:

• Sex and age matched controls (+/- 5 years)

• French speakers

• Normal visual examination with visual acuity of min 9/10

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Vision Loss

Intervention

Other:
• vision tests

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Estimation of the score of visual acuity by the logMAR chart		at inclusion	No
Secondary	Measure of lesion size		at inclusion	No
Secondary	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)	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	No