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 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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42678

Enrollment

360

Registered

2016-01-19

Start date

2016-03-02

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion 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 Have a similar refraction error, spherical and/or astigmatism of no more than 0,75 diopters.

Exclusion criteria

Exclusion criteria: - Patients with a systemic disease or ophthalmic disease. - Infants born at

Design outcomes

Primary

Measure	Time frame
H1a: There is no difference in the MT of treated and untreated patients and the fellow eye of the treated patient with anisometropic or strabismic amblyopia. H1b: There is no difference in the peripapillary RNFL of treated and untreated patients and the fellow eye of the treated patient with anisometropic or strabismic amblyopia. H2a: There is no difference in the MT of untreated patients with anisometropic or strabismic amblyopia compared to the MT of their fellow eye and healthy right eyes. H2b: There is no difference in the peripapillary RNFLT of untreated patients with anisometropic or strabismic amblyopia compared to the peripapillary RNFLT of their fellow eye and healthy right eyes. H3a: The macula of untreated patients with anisometropic or strabismic amblyopia is thicker than the macula of their fellow eye and healthy right eyes. H3b: The peripapillary RNFL of untreated patients with anisometropic or strabismic amblyopia is thicker than the peripapillary RNFL of their fellow eye and healthy right eyes. H4a: The peripapillary RNFL of the fellow eye in untreated and treated patients with anisometropic or strabismic amblyopia is thicker than the peripapillary RNFL of healthy right eyes. H4b: The macula of the fellow eye in untreated and treated patients with anisometropic or strabismic amblyopia is thicker than the macula of healthy right eyes.	—

Measure

Time frame

H*1a: There is no difference in the MT of treated and untreated patients and the fellow eye of the treated patient with anisometropic or strabismic amblyopia. H*1b: There is no difference in the peripapillary RNFL of treated and untreated patients and the fellow eye of the treated patient with anisometropic or strabismic amblyopia. H*2a: There is no difference in the MT of untreated patients with anisometropic or strabismic amblyopia compared to the MT of their fellow eye and healthy right eyes. H*2b: There is no difference in the peripapillary RNFLT of untreated patients with anisometropic or strabismic amblyopia compared to the peripapillary RNFLT of their fellow eye and healthy right eyes. H*3a: The macula of untreated patients with anisometropic or strabismic amblyopia is thicker than the macula of their fellow eye and healthy right eyes. H*3b: The peripapillary RNFL of untreated patients with anisometropic or strabismic amblyopia is thicker than the peripapillary RNFL of their fellow eye and healthy right eyes. H*4a: The peripapillary RNFL of the fellow eye in untreated and treated patients with anisometropic or strabismic amblyopia is thicker than the peripapillary RNFL of healthy right eyes. H*4b: The macula of the fellow eye in untreated and treated patients with anisometropic or strabismic amblyopia is thicker than the macula of healthy right eyes.

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Countries

Netherlands

Outcome results