Eye DiseasesPECTNCT05247099
Pediatric Eye Care Investigated Team
An observational study of Eye Diseases and Ocular Surface Disease, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
Use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. Understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Ocular Surface Disease, Systemic Disease
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Jul 2022
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Choose suitable patients from the ophthalmology hospital outpatient clinic or the ophthalmology and pediatric outpatient clinics of the Maternal and Child Health Hospital.
Who may be able to join
- 1. Age≤18
- 2. Cooperate with eye examination
- 3. Sign informed consent
Who cannot join
- 1. Cannot cooperate with eye examination
- 2. The researcher believes that the patient is not suitable to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Constructing Children's Eye Data Sharing Platform in Multiple Centers and Multiple Disciplines
Use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. Understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. Establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases.
Read the detailed description
Use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. Understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. Establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases.
All participants will be recruited from Zhongshan Ophthalmic Center, Sun Yat-sen University and Affiliated Foshan Maternity \& Child Healthcare Hospital, Southern Medical University. Only children with written informed consent from their parents can participate in this study.
Participants will be excluded for (1) age>18; (2) previous use of orthokeratology lenses or low-concentration atropine; (3) allergy to compound tropicamide eye drop; (4) any history of ocular surgery.
All participants will undergo optometry and biometric measurements by a trained team. The axial length (AL), central corneal thickness (CCT), anterior corneal radii of curvature, anterior chamber depth (ACD), lens thickness (LT), the curvature power of the central flat meridian (K1) and the central steep meridian (K2), the ocular surface and fundus will be measured. All measurements will be taken in room light condition (1000 lux).
- Conditions
- Eye Diseases, Ocular Surface Disease, Systemic Disease, Children
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with systemic diseases | Systemic diseases such as Nephritic syndrome, and other systemic diseases that can affect the eyes. | |
| healthy children | The exclusion criteria for the subjects were eye diseases or other systemic diseases that can affect the quality or volume of tears or the secretion of tears. These included 1. eyelid diseases: eyelid entropion, eyelid ectropion, ptosis, and palpebral dyskinesia; 2. conjunctival diseases: pterygium and conjunctivitis; 3. history of ocular surface chemical injury; 4. history of eye surgery within 6 months or history of retinal laser photocoagulation; 5. systemic diseases: Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave's disease, systemic lupus erythematosus, and others. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the non-invasive tear break-up time
change of the non-invasive tear break-up time in seconds
Measured: baseline, 24th months
change of the lipid layer of tear film
change of the lipid layer of tear film in nanometers
Measured: baseline, 24th months
Secondary outcomes (11)
vision
spherical equivalent in diopters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
intraocular pressure
the intraocular pressure in mm Hg
Measured: baseline, 6th months, 12th months, 18th months, 24th months
Eye axis length
Eye axis length in millimeters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
Anterior chamber depth
Anterior chamber depth in millimeters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
central corneal thickness
central corneal thickness in millimeters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
Lens thickness
Anterior chamber depth in millimeters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
Retina thickness
retina thickness in millimeters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
choroid thickness
choroid thickness in millimeters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
Corneal curvature
Corneal curvature in diopters
Measured: baseline, 6th months, 12th months, 18th months, 24th months
non-invasive tear break-up time
non-invasive tear break-up time in seconds
Measured: 6th months, 12th months, 18th months
the lipid layer of the tear film
the lipid layer of the tear film in nanometers
Measured: 6th months, 12th months, 18th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University ( Foshan Maternity & Child Healthcare Hospital)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247099
- Sponsor's protocol ID
- 2021KYPJ185
- Acronym
- PECT
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Z, Xie R, Luo R, Yao J, Jin L, Zhou Z, Chen K, Zhuo X, Zhu Y, Zhuo Y. Comparisons of Using Cycloplegic Biometry Versus Non-cycloplegic Biometry in the Calculation of the Cycloplegic Refractive Lens Powers. Ophthalmol Ther. 2022 Dec;11(6):2101-2115. doi: 10.1007/s40123-022-00569-w. Epub 2022 Sep 16.
PubMed 36114405
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constructing Children's Eye Data Sharing Platform in Multiple Centers and Multiple Disciplines
- ClinicalTrials.gov ID
- NCT05247099
- Acronym / sponsor ID
- PECT / 2021KYPJ185
- Conditions
- Eye Diseases, Ocular Surface Disease, Systemic Disease, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University ( Foshan Maternity & Child Healthcare Hospital)
- Study start
- Feb 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 18 Feb 2022 (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.
Use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. Understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. Establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases.
Detailed description
Use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. Understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. Establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases.
All participants will be recruited from Zhongshan Ophthalmic Center, Sun Yat-sen University and Affiliated Foshan Maternity \& Child Healthcare Hospital, Southern Medical University. Only children with written informed consent from their parents can participate in this study.
Participants will be excluded for (1) age>18; (2) previous use of orthokeratology lenses or low-concentration atropine; (3) allergy to compound tropicamide eye drop; (4) any history of ocular surgery.
All participants will undergo optometry and biometric measurements by a trained team. The axial length (AL), central corneal thickness (CCT), anterior corneal radii of curvature, anterior chamber depth (ACD), lens thickness (LT), the curvature power of the central flat meridian (K1) and the central steep meridian (K2), the ocular surface and fundus will be measured. All measurements will be taken in room light condition (1000 lux).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with systemic diseases | – | –Systemic diseases such as Nephritic syndrome, and other systemic diseases that can affect the eyes. |
| healthy children | – | –The exclusion criteria for the subjects were eye diseases or other systemic diseases that can affect the quality or volume of tears or the secretion of tears. These included 1. eyelid diseases: eyelid entropion, eyelid ectropion, ptosis, and palpebral dyskinesia; 2. conjunctival diseases: pterygium and conjunctivitis; 3. history of ocular surface chemical injury; 4. history of eye surgery within 6 months or history of retinal laser photocoagulation; 5. systemic diseases: Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave's disease, systemic lupus erythematosus, and others. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Choose suitable patients from the ophthalmology hospital outpatient clinic or the ophthalmology and pediatric outpatient clinics of the Maternal and Child Health Hospital.
Key inclusion criteria (3 listed)
- 1. Age≤18
- 2. Cooperate with eye examination
- 3. Sign informed consent
Key exclusion criteria (2 listed)
- 1. Cannot cooperate with eye examination
- 2. The researcher believes that the patient is not suitable to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of the non-invasive tear break-up time
Time frame: baseline, 24th months
change of the non-invasive tear break-up time in seconds
change of the lipid layer of tear film
Time frame: baseline, 24th months
change of the lipid layer of tear film in nanometers
11 secondary outcomes
vision
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
intraocular pressure
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
Eye axis length
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
Anterior chamber depth
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
central corneal thickness
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
Lens thickness
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
Retina thickness
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
choroid thickness
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
Corneal curvature
Time frame: baseline, 6th months, 12th months, 18th months, 24th months
non-invasive tear break-up time
Time frame: 6th months, 12th months, 18th months
the lipid layer of the tear film
Time frame: 6th months, 12th months, 18th months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 36114405Wang Z, Xie R, Luo R, Yao J, Jin L, Zhou Z, Chen K, Zhuo X, Zhu Y, Zhuo Y. Comparisons of Using Cycloplegic Biometry Versus Non-cycloplegic Biometry in the Calculation of the Cycloplegic Refractive Lens Powers. Ophthalmol Ther. 2022 Dec;11(6):2101-2115. doi: 10.1007/s40123-022-00569-w. Epub 2022 Sep 16.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases and Ocular Surface Disease, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingting Zhu (13580585671, ytzhu16@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the non-invasive tear break-up time (time frame: baseline, 24th months). The study lists 2 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 NCT05247099, which also lists 1 linked publication.
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 18 Feb 2022.