AMblyopia Treatment Through PErceptual Training in Children (AMPEL)

NCT02555384 | Withdrawn

• 1 other identifier: EKNZ2015-264
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Strabismic Amblyopia

Outcome Measures

Primary Outcomes (1)

• Crowding Ratio (CR)

  CR= Ratio of crowded versus uncrowded visual acuity. This is compared pre to post treatment

  7 weeks

Secondary Outcomes (1)

• hand-eye coordination

  7 weeks

Other Outcomes (2)

• longterm effect on CR

  7 months

• macular structure

  7 weeks and 7 months

Study Arms (2)

crowded drawing task

ACTIVE COMPARATOR

children will be asked to draw on a pattern presented under crowded viewing conditions.

Other: crowded drawing task

uncrowded drawing task

PLACEBO COMPARATOR

children will be asked to draw on a pattern presented under uncrowded viewing conditions

Other: uncrowded drawing task

Interventions

crowded drawing task OTHER

Marking inverted signs on a sheet where symbols are presented close to one another

crowded drawing task

uncrowded drawing task OTHER

Marking inverted signs on a sheet where there is a larger distance between symbols

uncrowded drawing task

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Basel: lead
• University Medical Center Nijmegen: collaborator

Related Publications (1)

• 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.

  PMID: 23950157 BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anja M Palmowski-Wolfe, Prof. med.

  University Basel, Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.med.

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 21, 2015
• Study Start: January 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 23, 2023

Record last verified: 2023-06