- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446077
Quantitatively Analysis of Fundus Structure Characteristics in Glaucoma Following Congenital Cataract Surgery
July 3, 2022 updated by: Haotian Lin, Sun Yat-sen University
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.
Study Overview
Status
Completed
Conditions
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).
Study Type
Observational
Enrollment (Actual)
129
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Zhongshan Ophthalmic Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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).
Description
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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
December 1st 2020 to March 31st 2021
|
Vascular-structural associations were assessed with Spearman correlation. (RNFL thickness and ONH vessels density, perfusion density)
Time Frame: December 1st 2020 to March 31st 2021
|
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.
|
December 1st 2020 to March 31st 2021
|
Diagnostic ability of GFCS was evaluated with area under the receiver operating curve (AUC).
Time Frame: December 1st 2020 to March 31st 2021
|
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).
|
December 1st 2020 to March 31st 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
June 26, 2022
First Submitted That Met QC Criteria
July 3, 2022
First Posted (Actual)
July 6, 2022
Study Record Updates
Last Update Posted (Actual)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 3, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCMPOH2022-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Cataract
-
Bambino Gesù Hospital and Research InstituteCompletedCataract Congenital
-
Sun Yat-sen UniversityCompletedCongenital Cataract
-
St. Erik Eye HospitalUnknown
-
Sun Yat-sen UniversityMinistry of Health, ChinaCompleted
-
Omer Othman AbdullahCompletedCongenital Cataract | Pediatric CataractIraq
-
Cambridge University Hospitals NHS Foundation TrustNot yet recruitingCongenital Cataract
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityCompleted
-
yin ying zhaoCompletedCongenital CataractChina
-
Wenzhou Medical UniversityCompleted