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

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (Inclusion and Exclusion criteria too stringent, no patient coluld be recruited)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
Sponsor:
Collaborator:
University Medical Center Nijmegen
Information provided by (Responsible Party):
Anja Palmowski-Wolfe, University of Basel

Tracking Information
First Submitted Date  ICMJE September 16, 2015
First Posted Date  ICMJE September 21, 2015
Last Update Posted Date May 7, 2021
Estimated Study Start Date  ICMJE January 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
Crowding Ratio (CR) [ Time Frame: 7 weeks ]
CR= Ratio of crowded versus uncrowded visual acuity. This is compared pre to post treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
hand-eye coordination [ Time Frame: 7 weeks ]
Outcome of a Beery test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 5, 2017)
  • longterm effect on CR [ Time Frame: 7 months ]
    CR Follow up 6 months after end of drawing training
  • macular structure [ Time Frame: 7 weeks and 7 months ]
    comparison of macular optical coherence tomography scan pre and post training
Original Other Pre-specified Outcome Measures
 (submitted: September 17, 2015)
  • longterm effect on CR [ Time Frame: 7 months ]
    CR Follow up 6 months after end of drawing training
  • macular structure [ Time Frame: 7 weeks and 7 months ]
    comparison of macular optical coherence tompgraphy scan pre and post training
 
Descriptive Information
Brief Title  ICMJE AMblyopia Treatment Through PErceptual Training in Children (AMPEL)
Official Title  ICMJE Improving Visual Functions in Young Children With Amblyopia Through Perceptual Learning
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Strabismic Amblyopia
Intervention  ICMJE
  • Other: crowded drawing task
    Marking inverted signs on a sheet where symbols are presented close to one another
  • Other: uncrowded drawing task
    Marking inverted signs on a sheet where there is a larger distance between symbols
Study Arms  ICMJE
  • Active Comparator: crowded drawing task
    children will be asked to draw on a pattern presented under crowded viewing conditions.
    Intervention: Other: crowded drawing task
  • Placebo Comparator: uncrowded drawing task
    children will be asked to draw on a pattern presented under uncrowded viewing conditions
    Intervention: Other: uncrowded drawing task
Publications * Huurneman B, Boonstra FN, Cox RF, van Rens G, Cillessen AH. Perceptual learning in children with visual impairment improves near visual acuity. Invest Ophthalmol Vis Sci. 2013 Sep 17;54(9):6208-16. doi: 10.1167/iovs.13-12220.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 3, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2015)
60
Actual Study Completion Date  ICMJE November 30, 2020
Actual Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02555384
Other Study ID Numbers  ICMJE EKNZ2015-264
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anja Palmowski-Wolfe, University of Basel
Study Sponsor  ICMJE University of Basel
Collaborators  ICMJE University Medical Center Nijmegen
Investigators  ICMJE
Principal Investigator: Anja M Palmowski-Wolfe, Prof. med. University Basel, Eye Hospital
PRS Account University of Basel
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP