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Clinical Trials/NL-OMON42678
NL-OMON42678
Recruiting
Not Applicable

Comparison of the retinal thickness and retinal nerve fibre layer thickness using HD-OCT between treated and untreated children with anisometropic or strabismic amblyopia in comparison to healthy eyes. - Comparison of MT and RNFLT between treated and untreated amblyopic children

Canisius Wilhelmina Ziekenhuis0 sites360 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amblyopia
Sponsor
Canisius Wilhelmina Ziekenhuis
Enrollment
360
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Canisius Wilhelmina Ziekenhuis

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible to participate in this study, a patient must meet the following criteria:;Children cooperative for OCT examination.
  • The refraction error must be within the range of \-20 to \+20 diopters due to limitations of the OCT device.;Untreated strabismic and anisometropic amblyopes:
  • Within the age range of three to six years.
  • With at least a two line visual acuity difference between the amblyopic and the fellow eye.
  • Teated strabismic and anisometropic amblyopes:
  • Within the age range of seven to twelve years.
  • With equal (1\.0 snellen) or nearly equal visual acuity, no more than one line difference.
  • With at least a two line visual acuity difference between the amblyopic and the fellow eye before treatment.
  • Treated as well as untreated anisometropic amblyopes need to have a difference in refraction error of at least 1 diopter spherical and/or 1 diopter astigmatic difference. ;Age matched controls:
  • Are orthotropic or have a slight phoria on cover testing with quick recovery

Exclusion Criteria

  • \- Patients with a systemic disease or ophthalmic disease.
  • \- Infants born at \<32 weeks post conception.
  • \- Infants with ROP.
  • \- Patients with nystagmus or eccentric fixation.

Outcomes

Primary Outcomes

Not specified

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