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Glaucoma SecondaryNCT05446077

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

An observational study of Glaucoma Secondary and Congenital Cataract, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Glaucoma Secondary, Congenital Cataract
How many people
129 participants
Where
1 siteChina
Study dates
1 Dec 2020to 1 Mar 2021
How long will I take part?
4 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: This study is a cross-sectional clinical study. Including children who were followed up in the pediatric cataract clinic of our hospital from December 1, 2020, to March 31, 2021, and had been diagnosed with GFCS, as well as patients diagnosed with non-congenital cataract extraction after surgery(NGFCS).

NGFCS Group Inclusion Criteria:

  • 1) The guardian of the child voluntarily signed the informed consent;
  • 2) 4 years old ≤ age ≤ 18 years old, regardless of gender;
  • 3) In line with the diagnostic criteria of NGFCS; that is, cataract extraction surgery was performed in our hospital, with no restrictions on the eye of the surgery, and implantation / or no intraocular lens implantation;
  • 4) No other serious postoperative complications other than GFCS occurred after cataract extraction, such as retinal detachment, vitreous hemorrhage, choroidal detachment, etc.
  • 5) The children included in this study need to have good gaze ability. Considering that the visual acuity of CC children after cataract extraction is lower than that of normal children of the same age, the best-corrected visual acuity of the included patients is ≤0.4logMAR (implanted IOL or wearing frame glasses, Contact lenses to correct vision), can better cooperate to complete OCT and OCTA examinations;

GFCS Group Inclusion Criteria:

  • 1) The guardian of the child voluntarily signed the informed consent;
  • 2) Clinical diagnosis of GFCS
  • 3) The age of 4 years old is less than or equal to 18 years old, and the gender is not limited;
  • 4) The diagnostic criteria of GFCS are met; one or both eyes are affected; Tremor, best corrected visual acuity ≤0.7logMAR, can better cooperate with OCT and OCTA examination;

The diagnostic criteria of GFCS： Childhood: based on national criteria, <18 years old (USA); 16 years old (UK, Europe,UNICEF) Childhood glaucoma: two or more of the following are required

  1. Intraocular pressure: >21 mmHg (investigator discretion on method of measurement and if EUA data alone is sufficient).
  2. Visual fields: reproducible visual field defect that is consistent with glaucomatous optic neuropathy with no other observable reason for the visual field defect.
  3. Axial length: progressive myopia or myopic shift with increased ocular dimensions that outpace normal growth.
  4. 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.
  5. 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Quantitatively Analysis of Fundus Structure Characteristics in Glaucoma Following Congenital Cataract Surgery (GFCS) Using Optical Coherence Tomography Angiography

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.

Read the detailed description

A cross-sectional study. A total of 129 congenital cataract patients after congenital cataract extraction (40 in GFCS and 89 in NGFCS) were enrolled in this study from December 2020 to March 2021. All participants, age range from 4 to 18 years old, completed OCT examinations (including macular structure parameters, optic nerve fiber layer thickness periphery retinal nerve fiber layer [pRNFL], and sub foveal choroidal thickness [SFCT]). All the NGFCS participants underwent OCTA examinations (including vessel density (VD) and perfusion density (PD) of macular and peripapillary area.). Linear regression models were used to examine the effect of various factors on different ocular parameters. Vascular-structural associations were assessed with Spearman correlation. Diagnostic ability was evaluated with area under the receiver operating curve (AUC).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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）

    All participants completed OCT examinations (including macular structure parameters, optic nerve fiber layer thickness periphery retinal nerve fiber layer [pRNFL], and sub foveal choroidal thickness [SFCT]). All the NGFCS participants underwent OCTA examinations (including vessel density (VD) and perfusion density (PD) of macular and peripapillary area.). Linear regression models were used to examine the effect of various factors on different ocular parameters with demographic factors.

    Measured: December 1st 2020 to March 31st 2021

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

    All participants completed OCT examinations (including macular structure parameters, optic nerve fiber layer thickness periphery retinal nerve fiber layer [pRNFL], and sub foveal choroidal thickness [SFCT]). All the NGFCS participants underwent OCTA examinations (including vessel density (VD) and perfusion density (PD) of macular and peripapillary area.). Vascular-structural associations were assessed with Spearman correlation.

    Measured: December 1st 2020 to March 31st 2021

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

    All participants completed OCT examinations (including macular structure parameters, optic nerve fiber layer thickness periphery retinal nerve fiber layer [pRNFL], and sub foveal choroidal thickness [SFCT]). All the NGFCS participants underwent OCTA examinations (including vessel density (VD) and perfusion density (PD) of macular and peripapillary area.). Diagnostic ability of GFCS was evaluated with area under the receiver operating curve (AUC).

    Measured: December 1st 2020 to March 31st 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start1 Dec 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
129 participants (actual)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05446077
Sponsor's protocol ID
CCMPOH2022-01
Status last verified
Jul 2022
First submitted
26 Jun 2022
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma Secondary and Congenital Cataract, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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） (time frame: December 1st 2020 to March 31st 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05446077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.

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