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AMblyopia Treatment Through PErceptual Training in Children (AMPEL) (AMPEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02555384
Recruitment Status : Withdrawn (Inclusion and Exclusion criteria too stringent, no patient coluld be recruited)
First Posted : September 21, 2015
Last Update Posted : May 7, 2021
University Medical Center Nijmegen
Information provided by (Responsible Party):
Anja Palmowski-Wolfe, University of Basel

Brief Summary:

Amblyopia, affects 4% of the population. In the presence of a normal retina and optic nerve, the visual cortex does not develop normally secondary to the amblyopic eye being at a disadvantage in the sensitive period such as in strabismus. Amblyopia is associated with visuospatial disorders, and poor to absent stereopsis. Amblyopia is treated by occlusion of the non- amblyopic eye in childhood. The present study aims to evaluate the effectiveness of perceptual learning (PL), that is a training of visual drawing tasks (12 sessions of 30 Minutes duration) with crowding (c) for children with amblyopia compared to an amblyopic control group with a placebo drawing task.

Arm 1: Crowded (PLc)- Training with small spacing Arm 2: Uncrowded (PLu)- Training with large spacing Prior to this, a small group will help optimize parameters such as contrast and distance of visual objects presented

Condition or disease Intervention/treatment Phase
Strabismic Amblyopia Other: crowded drawing task Other: uncrowded drawing task Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Visual Functions in Young Children With Amblyopia Through Perceptual Learning
Estimated Study Start Date : January 2020
Actual Primary Completion Date : November 30, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Active Comparator: crowded drawing task
children will be asked to draw on a pattern presented under crowded viewing conditions.
Other: crowded drawing task
Marking inverted signs on a sheet where symbols are presented close to one another

Placebo Comparator: uncrowded drawing task
children will be asked to draw on a pattern presented under uncrowded viewing conditions
Other: uncrowded drawing task
Marking inverted signs on a sheet where there is a larger distance between symbols

Primary Outcome Measures :
  1. Crowding Ratio (CR) [ Time Frame: 7 weeks ]
    CR= Ratio of crowded versus uncrowded visual acuity. This is compared pre to post treatment

Secondary Outcome Measures :
  1. hand-eye coordination [ Time Frame: 7 weeks ]
    Outcome of a Beery test

Other Outcome Measures:
  1. longterm effect on CR [ Time Frame: 7 months ]
    CR Follow up 6 months after end of drawing training

  2. macular structure [ Time Frame: 7 weeks and 7 months ]
    comparison of macular optical coherence tomography scan pre and post training

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: children aged 4-8 years with

  • strabismic amblyopia
  • cycloplegic refraction corrected at least 3 months prior to enrolment
  • Reliable test results for two previous examinations
  • absence of ocular conditions other than strabismus, amblyopia and corrected refractive error

Exclusion Criteria:

  • inability to perform reliably when examined
  • inability to draw
  • unstable visual results on 2 previous examinations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02555384

Sponsors and Collaborators
University of Basel
University Medical Center Nijmegen
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Principal Investigator: Anja M Palmowski-Wolfe, Prof. med. University Basel, Eye Hospital
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Responsible Party: Anja Palmowski-Wolfe, Prof., University of Basel Identifier: NCT02555384    
Other Study ID Numbers: EKNZ2015-264
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases