The Effect of Early Glasses on the Development of Amblyopia

NCT04740593 | Active Not Recruiting

• 1 other identifier: ABR number: 76412
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia; Refractive Errors

Keywords

Glasses; Vision screening

Outcome Measures

Primary Outcomes (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)

  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.

  Final examination, time = 30-36 months

Secondary Outcomes (5)

• Prevalence of amblyopia at age 1

  First examination, time = 0

• Type and magnitude of refractive error at age 1

  First examination, time = 0

• 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).

  Final examination, time = 30-36 months

• Pre-literacy skills in the intervention and control group at age 4

  Final examination, time = 30-36 months

• In all groups, occurrence of strabismus at the final examination

  Final examination, time = 30-36 months

Other Outcomes (6)

• Electronically measured compliance with spectacles wearing

  Yet to be defined, probably time = 12-24 months

• 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.

  First to final examination, time = 0 to 30-36 months

• Family history for ocular disease

  First examination, time = 0

Study Arms (3)

Group 1 - High refractive error: Intervention

EXPERIMENTAL

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

Group 2 - High refractive error: Control

OTHER

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

Group 3 - Mild or no refractive error

OTHER

Children with mild or no refractive error (i.e. not exceeding the AAPOS 2003 criteria) at age one

Other: First measurement only

Interventions

Orthoptic care with the prescription of glasses from age 12-18 months onwards OTHER

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.

Also known as: Glasses, Spectacles

Group 1 - High refractive error: Intervention

Orthoptic care without the prescription of glasses from age 12-18 months onwards OTHER

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 2 - High refractive error: Control

First measurement only OTHER

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.

Group 3 - Mild or no refractive error

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Registered at one of the participating CHCs;
• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Dept. of Ophthalmology Erasmus Medical Center

Rotterdam, NL3000CA, Netherlands

Location

Related Publications (1)

• Donahue SP, Arnold RW, Ruben JB; AAPOS Vision Screening Committee. Preschool vision screening: what should we be detecting and how should we report it? Uniform guidelines for reporting results of preschool vision screening studies. J AAPOS. 2003 Oct;7(5):314-6. doi: 10.1016/s1091-8531(03)00182-4. No abstract available.

  PMID: 14566312 BACKGROUND

MeSH Terms

Conditions

Amblyopia; Refractive Errors

Interventions

Eyeglasses

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

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Huibert J Simonsz, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: February 5, 2021
• Study Start: May 10, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)