KeratoconusKCLDNCT06722937
The Collagen Factors of Rapid Progression of Keratoconus in Children.
An observational study of Keratoconus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this observational study was to understand the differences in clinical features and mechanisms of keratoconus between children and adults. The main questions it aimed to answer as follows: (1) to understand the characteristics of keratoconus in Chinese children. Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Observation
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2023to 13 Apr 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Consistently enrolled subjects aged between 10 and 50 years old with keratoconus and myopic astigmatism who visited the refractive clinic from April 2023 to April 2024
Who may be able to join
- ① Patients with keratoconus who visit the refractive clinic.
- The height of the posterior corneal surface is greater than 16 microns under the Pentacam corneal topography.
- ARTAve < 424 microns, ARTMax < 339 microns.
- Clinical non-inflammatory or traumatic corneal thinning and corneal astigmatism.
- Aged between 10 and 50 years old, no gender restrictions.
- Agree to accept and complete follow-up examinations on time. ④ I and my guardian understand and agree to participate in this clinical trial and sign the informed consent form.
Who cannot join
- ① There is a history of contact lens wearing in the last four weeks.
- poor fixation and can not cooperate with the examination. ③ History of eye trauma and surgery (including corneal collagen cross-linking surgery).
- History of other related eye diseases: corneal disease, glaucoma, retinal choroid disease, etc..
- ⑤ severe eye diseases affecting imaging such as dry eye, conjunctivitis and pterygium.
- ⑥ Any systemic disease affecting eye morphology and refractive interstitium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center,Sun Yat-Sen University
Guangzhou, Guangdong
Yanjie Yan, +86 20 6661 0729, zocethics@163.com
Junwen Zeng, PhD
About this study
Official title: The Collagen Factors of Rapid Progression of Keratoconus in Children: an Observational Cohort Study of the Physiological Parameter
The purpose of this observational study was to understand the differences in clinical features and mechanisms of keratoconus between children and adults. The main questions it aimed to answer as follows: (1) to understand the characteristics of keratoconus in Chinese children. (2) to observe corneal stromal cells at the cytological level using in vivo corneal laser confocal microscopy and explore the pathogenesis.
Read the detailed description
Keratoconus is a progressive and asymmetric corneal dilation disease, in which the cornea presents as a conical protrusion, leading to irregular astigmatism, progressive myopia, corneal thinning, and subsequent visual impairment. If left untreated, acute corneal edema may occur in the late stage, resulting in a sharp decline in vision. This disease is a binocular disease and can occur unilaterally first. The incidence rate of the general population is 1/2000. Most of the diseases described in the literature began in adolescence, and about 90% of the patients were diagnosed at the age of 10. Some literature reported that the youngest patient was 4 years old, and the disease generally remained stable until about 40 years old.
Currently, research on pediatric keratoconus mainly includes the prevalence and morphological characteristics, as well as the progression of corneal collagen cross-linking surgery. The younger onset age of KC is often associated with rapid progression and late stage disease diagnosis. Scholars have observed that 88% of children develop KC after one year of diagnosis, and advocate for early corneal collagen cross-linking treatment for these children's eyes. However, the reasons for the onset and progression of keratoconus in children at a young age are not yet clear.
Due to the young age of onset and unclear reasons for the progression of pediatric keratoconus in clinical practice, as well as insufficient research on pediatric keratoconus in recent years, the clinical characteristics of pediatric keratoconus are still lacking, and the pathogenesis of pediatric keratoconus is still unclear. Therefore, this study aims to compare pediatric keratoconus with adult keratoconus, extract the characteristics of pediatric keratoconus, and use a live corneal laser confocal microscope to observe the stromal cellular structure inside pediatric keratoconus, in order to provide some clinical reference for the pathological understanding of pediatric keratoconus.
- Conditions
- Keratoconus
- Being tested
- Observation
- Keywords
- keratoconus, pediatric, Corneal biomechanics, collagen
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observe the clinical natural changes of eye parameters of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus group of children | Not described Receives: Other: Observation | |
| Keratoconus group of adult | Not described Receives: Other: Observation | |
| Control group of children | Not described Receives: Other: Observation | |
| Control group of adult | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thinnest corneal thickness
Measurement of the thinnest point corneal thickness using the Three-Dimensional Anterior Segment Analyzer.
Measured: 1 year
Kmax
Measurement of the maximum keratometry from the anterior corneal surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Measured: 1 year
ISV
Measurement of the index of surface variance of corneal front surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Measured: 1 year
IVA
Measurement of the index of vertical asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Measured: 1 year
IHA
Measurement of the index of height asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Measured: 1 year
IHD
Measurement of the index of height decentration the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
Measured: 1 year
CBI
Measurement of the corvis biomechanical index of cornea using the Corneal Biomechanical Analyzer.
Measured: 1 year
TBI
Measurement of the tomographical biomechanical index of cornea using the Corneal Biomechanical Analyzer.
Measured: 1 year
SPA1
Measurement of the stiffness parameter at the first applanation of cornea using the Corneal Biomechanical Analyzer.
Measured: 1 year
SSI
Measurement of the stress-strain index of cornea using the Corneal Biomechanical Analyzer.
Measured: 1 year
Corneal stromal cell density
Measurement of the corneal stromal cell density using in vivo corneal confocal microscopy.
Measured: 1 year
Mutations in collagen related genes
The expressions and mutations in collagen related genes(COL4A3, COL4A4 COL5A1, COL6A2, TGFBI, LOX, MMP9, TIMP1) using the DNA Sequencing Technology.
Measured: 1 year
Secondary outcomes (4)
Frame best corrected visual acuity
Measurement of best-corrected visual acuity of eye using visual charts.
Measured: 1 year
Spherical power
Measurement of myopic refraction of eye using subjective refraction methods.
Measured: 1 year
Cylindrical power
Measurement of astigmatism of eye using subjective refraction methods.
Measured: 1 year
Axial length
Measurement of axial length of eye using IOL-Master 700.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start14 Apr 2023
- Primary completion13 Apr 2025 (estimated)
- Study completion13 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722937
- Sponsor's protocol ID
- 2023KYPJ328
- Acronym
- KCLD
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share our Study protocol, Statistical analysis plan, Informed consent form, Clinical study report.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Collagen Factors of Rapid Progression of Keratoconus in Children: an Observational Cohort Study of the Physiological Parameter
- ClinicalTrials.gov ID
- NCT06722937
- Acronym / sponsor ID
- KCLD / 2023KYPJ328
- Conditions
- Keratoconus
- Keywords
- keratoconus, pediatric, Corneal biomechanics, collagen
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 13 Apr 2025 (estimated)
- Study completion
- 13 Apr 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study was to understand the differences in clinical features and mechanisms of keratoconus between children and adults. The main questions it aimed to answer as follows: (1) to understand the characteristics of keratoconus in Chinese children. (2) to observe corneal stromal cells at the cytological level using in vivo corneal laser confocal microscopy and explore the pathogenesis.
Detailed description
Keratoconus is a progressive and asymmetric corneal dilation disease, in which the cornea presents as a conical protrusion, leading to irregular astigmatism, progressive myopia, corneal thinning, and subsequent visual impairment. If left untreated, acute corneal edema may occur in the late stage, resulting in a sharp decline in vision. This disease is a binocular disease and can occur unilaterally first. The incidence rate of the general population is 1/2000. Most of the diseases described in the literature began in adolescence, and about 90% of the patients were diagnosed at the age of 10. Some literature reported that the youngest patient was 4 years old, and the disease generally remained stable until about 40 years old.
Currently, research on pediatric keratoconus mainly includes the prevalence and morphological characteristics, as well as the progression of corneal collagen cross-linking surgery. The younger onset age of KC is often associated with rapid progression and late stage disease diagnosis. Scholars have observed that 88% of children develop KC after one year of diagnosis, and advocate for early corneal collagen cross-linking treatment for these children's eyes. However, the reasons for the onset and progression of keratoconus in children at a young age are not yet clear.
Due to the young age of onset and unclear reasons for the progression of pediatric keratoconus in clinical practice, as well as insufficient research on pediatric keratoconus in recent years, the clinical characteristics of pediatric keratoconus are still lacking, and the pathogenesis of pediatric keratoconus is still unclear. Therefore, this study aims to compare pediatric keratoconus with adult keratoconus, extract the characteristics of pediatric keratoconus, and use a live corneal laser confocal microscope to observe the stromal cellular structure inside pediatric keratoconus, in order to provide some clinical reference for the pathological understanding of pediatric keratoconus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Keratoconus group of children | – | Other: Observation |
| Keratoconus group of adult | – | Other: Observation |
| Control group of children | – | Other: Observation |
| Control group of adult | – | Other: Observation |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Consistently enrolled subjects aged between 10 and 50 years old with keratoconus and myopic astigmatism who visited the refractive clinic from April 2023 to April 2024
Key inclusion criteria (6 listed)
- ① Patients with keratoconus who visit the refractive clinic.
Key exclusion criteria (5 listed)
- ① There is a history of contact lens wearing in the last four weeks.
- ⑤ severe eye diseases affecting imaging such as dry eye, conjunctivitis and pterygium.
- ⑥ Any systemic disease affecting eye morphology and refractive interstitium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObserve the clinical natural changes of eye parameters of the subjects. | Other | Control group of adult, Control group of children, Keratoconus group of adult, Keratoconus group of children |
Primary outcome
Thinnest corneal thickness
Time frame: 1 year
Measurement of the thinnest point corneal thickness using the Three-Dimensional Anterior Segment Analyzer.
Kmax
Time frame: 1 year
Measurement of the maximum keratometry from the anterior corneal surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
ISV
Time frame: 1 year
Measurement of the index of surface variance of corneal front surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IVA
Time frame: 1 year
Measurement of the index of vertical asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IHA
Time frame: 1 year
Measurement of the index of height asymmetry of the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
IHD
Time frame: 1 year
Measurement of the index of height decentration the corneal anterior surface using the Pentacam Three-Dimensional Anterior Segment Analyzer.
CBI
Time frame: 1 year
Measurement of the corvis biomechanical index of cornea using the Corneal Biomechanical Analyzer.
TBI
Time frame: 1 year
Measurement of the tomographical biomechanical index of cornea using the Corneal Biomechanical Analyzer.
SPA1
Time frame: 1 year
Measurement of the stiffness parameter at the first applanation of cornea using the Corneal Biomechanical Analyzer.
SSI
Time frame: 1 year
Measurement of the stress-strain index of cornea using the Corneal Biomechanical Analyzer.
Corneal stromal cell density
Time frame: 1 year
Measurement of the corneal stromal cell density using in vivo corneal confocal microscopy.
Mutations in collagen related genes
Time frame: 1 year
The expressions and mutations in collagen related genes(COL4A3, COL4A4 COL5A1, COL6A2, TGFBI, LOX, MMP9, TIMP1) using the DNA Sequencing Technology.
4 secondary outcomes
Frame best corrected visual acuity
Time frame: 1 year
Spherical power
Time frame: 1 year
Cylindrical power
Time frame: 1 year
Axial length
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Registration information of this study in ChinaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share our Study protocol, Statistical analysis plan, Informed consent form, Clinical study report.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Zhongshan Ophthalmic Center, 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?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Li, MD (+86 188 1149 6522, canotoday@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thinnest corneal thickness (time frame: 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.