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 range

4 Years – 18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

4 Years – 18 Years

Sex

ALL

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