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The Effect of Early Glasses on the Development of Amblyopia (EGS)

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ClinicalTrials.gov Identifier: NCT04740593
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Huib Simonsz, Erasmus Medical Center

Brief Summary:
In a randomized controlled trial, we will establish whether early glasses for high refractive error at age one reduce the development of amblyopia between age one and four. As a secondary outcome early literacy will be compared in groups with and without glasses.

Condition or disease Intervention/treatment Phase
Amblyopia Refractive Errors Other: Orthoptic care with the prescription of glasses from age 12-18 months onwards Other: Orthoptic care without the prescription of glasses from age 12-18 months onwards Other: First measurement only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will only have access to coded data, which cannot be traced back to the individual participants, from the electronic Case Report Forms in Castor, a cloud-based clinical data management platform.
Primary Purpose: Prevention
Official Title: The Early Glasses Study: Can Early Glasses Prevent the Development of Amblyopia in Children With High Refractive Errors at Age One
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - High refractive error: Intervention
Children with high refractive error (i.e. exceeding the AAPOS 2003 criteria) at age one, who are randomly assigned to the intervention group
Other: Orthoptic care with the prescription of glasses from age 12-18 months onwards
Children assigned to the intervention group (group 1) will receive orthoptic care, including exams 1-3 (depending on the refractive error) times a year, and glasses, based on accurate determinations of refractive error by retinoscopy in cycloplegia by the study orthoptists at age 12-18 months. The spectacles for the children in this study will be provided by the study via their optician without costs.
Other Names:
  • Glasses
  • Spectacles

Group 2 - High refractive error: Control
Children with high refractive error (i.e. exceeding the AAPOS 2003 criteria) at age one, who are randomly assigned to the control group
Other: Orthoptic care without the prescription of glasses from age 12-18 months onwards
Children with high refractive error in the control group (group 2) will also receive orthoptic care, including exams 1-3 (depending on the refractive error) times a year, but they will not receive glasses.

Group 3 - Mild or no refractive error
Children with mild or no refractive error (i.e. not exceeding the AAPOS 2003 criteria) at age one
Other: First measurement only
Children who have no or mild refractive error (group 3), the majority of all children, will be examined by the study orthoptists only once at the age of 12-18 months, after which youth health care (YHC) physicians and nurses will continue standard vision screening at CHCs, as part of screening for general health disorders and vaccinations. Visual acuity is measured routinely at 42-48 months as part of standard vision screening.




Primary Outcome Measures :
  1. The occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and in the control group (group 2) [ Time Frame: Final examination, time = 30-36 months ]
    The prevalence of amblyopia at age 4 stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and the control group (group 2) at the final examination. When a child is diagnosed with amblyopia during the course of the study, the child's visual acuity at the moment of referral will be used as primary outcome, after correcting for age.


Secondary Outcome Measures :
  1. Prevalence of amblyopia at age 1 [ Time Frame: First examination, time = 0 ]
    Defined/noted by study orthoptist

  2. Type and magnitude of refractive error at age 1 [ Time Frame: First examination, time = 0 ]
    Measured by retinoscopy in cyloplegia

  3. Occurrence of amblyopia at age 4 stratified according to visual acuity of the amblyopic eye at the final examination in the children without refractive error at age 1 (group 2 and 3). [ Time Frame: Final examination, time = 30-36 months ]
    Defined/noted by study orthoptist

  4. Pre-literacy skills in the intervention and control group at age 4 [ Time Frame: Final examination, time = 30-36 months ]
    Measured with the Test of Preschool Early Literacy (TOPEL)

  5. In all groups, occurrence of strabismus at the final examination [ Time Frame: Final examination, time = 30-36 months ]
    Defined/noted by study orthoptist


Other Outcome Measures:
  1. Electronically measured compliance with spectacles wearing [ Time Frame: Yet to be defined, probably time = 12-24 months ]
    During home visits an Occlusion Dose Monitor (ODM) will be fixed firmly to the spectacles next to the temple by imbedding the ODM in an occlusion eye patch for one week. After one week it will be removed during a subsequent home visit and the recording will be downloaded.

  2. The evolution of hyperopia, anisometropia and astigmatism, all three based on the means of these three types of discrete variables, measured repeatedly between age 1 and 4 by retinoscopy in cycloplegia in all children with high refractive error at age 1. [ Time Frame: First to final examination, time = 0 to 30-36 months ]
    It involves three longitudinal outcome measures, based on the repeated measurement of the three types of refractive errors that are of interest for this study from age 1 to 4 (each potentially stratified for severity of refractive error at age 1). A Mixed Model linear regression model will be use to correct for inner participant data clustering.

  3. Family history for ocular disease [ Time Frame: First examination, time = 0 ]
    Anamnesis

  4. Ethnicity [ Time Frame: First examination, time = 0 ]
    Anamnesis

  5. Parental level of education, social economic status and language skill [ Time Frame: First examination, time = 0 ]
    Anamnesis

  6. Gender [ Time Frame: First examination, time = 0 ]
    Anamnesis



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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Registered at one of the participating CHCs;
  • 12-18 months of age;
  • Voluntary approval for participation by the parents or legal representative/guardian with provided written informed consent;
  • Willingness of the parents/guardian(s) to comply with the study procedures

Exclusion Criteria:

  • Congenital syndromes;
  • Psychomotor retardation;
  • Known hereditary defects;
  • Known cardiac disease;
  • Severe comorbidity;
  • Children's whose parents do not agree to cyclopegia with the use of cyclopentolate 1% eye drops for orthoptic examination (retinacopy) by the study orthoptist;
  • Refractive error higher than the AAPOS criteria twofold (i.e. hyperopia >7 dioptres, anisometropia >3 dioptres and astigmatism of >3 dioptres at 90º or 180º and >2 dioptres in oblique axis (>10º eccentric to 90º or 180º);
  • Strabismus;
  • Amblyopia;
  • Ptosis;
  • Cataract or other media opacity;
  • Other ophthalmic disease requiring immediate referral;

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 ClinicalTrials.gov identifier (NCT number): NCT04740593


Contacts
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Contact: Huibert J Simonsz, MD, PhD +31651187878 simonsz@compuserve.com
Contact: Annelies E Bruinenberg, MD +31107043275 a.bruinenberg@erasmusmc.nl

Locations
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Netherlands
Dept. of Ophthalmology Erasmus Medical Center
Rotterdam, Netherlands, NL3000CA
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Principal Investigator: Huibert J Simonsz, MD, PhD Erasmus Medical Center
Publications:
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Responsible Party: Huib Simonsz, Principal Investigator, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04740593    
Other Study ID Numbers: ABR number: 76412
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huib Simonsz, Erasmus Medical Center:
Glasses
Vision screening
Additional relevant MeSH terms:
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Amblyopia
Refractive Errors
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors