CompletedNot Applicable

Quantitatively Analysis of Fundus Structure Characteristics in Glaucoma Following Congenital Cataract Surgery

China129 participantsStarted 2020-12-01

Plain-language summary

To quantitatively analyze the fundus structure and microvascular characteristics of GFCS and non-GFCS (NGFCS) using optical coherence tomography angiography (OCTA), to explore the vascular-structural association, and to assess the diagnostic abilities of structure parameters.

Who can participate

Age range4 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Intraocular pressure: \>21 mmHg (investigator discretion on method of measurement and if EUA data alone is sufficient).
✓. Visual fields: reproducible visual field defect that is consistent with glaucomatous optic neuropathy with no other observable reason for the visual field defect.
✓. Axial length: progressive myopia or myopic shift with increased ocular dimensions that outpace normal growth.
✓. Cornea: findings including Haab striae, corneal diameter \>11mm in newborns, \>12mm in children younger than 1 year old, and \>13mm in children older than 1 year old.
✓. Optic nerve: progressive increase in cup-disc ratio, cup-disc asymmetry of 0.2 when optic discs are of similar size, and focal rim thinning.

What they're measuring

Linear regression models were used to examine the effect of various factors on different ocular parameters with demographic factors. （RNFL thickness with gender, age, axial length）

Timeframe: December 1st 2020 to March 31st 2021

Vascular-structural associations were assessed with Spearman correlation. (RNFL thickness and ONH vessels density, perfusion density)

Timeframe: December 1st 2020 to March 31st 2021

Diagnostic ability of GFCS was evaluated with area under the receiver operating curve (AUC).

Timeframe: December 1st 2020 to March 31st 2021

Trial details

NCT IDNCT05446077

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Glaucoma Secondary trials

Who can participate

Age range4 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Intraocular pressure: \>21 mmHg (investigator discretion on method of measurement and if EUA data alone is sufficient).
✓. Visual fields: reproducible visual field defect that is consistent with glaucomatous optic neuropathy with no other observable reason for the visual field defect.
✓. Axial length: progressive myopia or myopic shift with increased ocular dimensions that outpace normal growth.
✓. Cornea: findings including Haab striae, corneal diameter \>11mm in newborns, \>12mm in children younger than 1 year old, and \>13mm in children older than 1 year old.
✓. Optic nerve: progressive increase in cup-disc ratio, cup-disc asymmetry of 0.2 when optic discs are of similar size, and focal rim thinning.

What they're measuring

Linear regression models were used to examine the effect of various factors on different ocular parameters with demographic factors. （RNFL thickness with gender, age, axial length）

Timeframe: December 1st 2020 to March 31st 2021

Vascular-structural associations were assessed with Spearman correlation. (RNFL thickness and ONH vessels density, perfusion density)

Timeframe: December 1st 2020 to March 31st 2021

Diagnostic ability of GFCS was evaluated with area under the receiver operating curve (AUC).

Timeframe: December 1st 2020 to March 31st 2021