Pediatric CataractNCT05472844
The Cohort Study of Pediatric Cataract
An observational study of Pediatric Cataract, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Cataract
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2022to 1 Feb 2032
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This is a retrospective-prospective bidirectional cohort study. Patients aged < 18 yo at the 1st visit are enrolled.
Who may be able to join
- aged < 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent
Who cannot join
- adults
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
Guangzhou, Guangdong, 510060
Zhenzhen Liu, PhD, +020 66618932, liuzhenzhen@gzzoc.com
Yizhi Liu, PhD
About this study
This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.
Read the detailed description
Pediatric cataract, one of the leading causes of childhood blindness globally, is complex and of great difficulty in treatment. Pediatric patients with cataract (congenital, traumatic or complicated) are enrolled. In this study, investigators will compare ocular parameter changes, different surgical/vision timing or recovery strategies and adverse effects among young children （age < 18 yo）before and after cataract surgery. The influence on psychology and cognitive function will be taken into consideration as well. The whole blood samples of participants and parents are collected and retained in our biobank for gene sequencing, hoping to explore the genetic factors in association with pathogenesis. For children received cataract surgery, samples of partial anterior capsular tissue and 1 ml aqueous humor were collected during operation for further analysis. Multimodal artificial intelligence analyses are performed to establish accurate diagnosis/treatment scheme and disease prediction model.
- Conditions
- Pediatric Cataract
- Keywords
- congenital cataract, traumatic cataract, complicated cataract, ocular structure parameters, surgical/vision recovery timing and strategies, postoperative adverse effects, psychologic and cognitive function, artificial intelligence
- Medical subject headings
- Capsule Opacification
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity changes
Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time
Measured: Baseline and through study completion, an average of 1 year
Intraocular pressure changes
Intraocular pressures are measured by NCT machine
Measured: Baseline and through study completion, an average of 1 year
Refractive power changes
Refractive power are measured at baseline and every visit at least every 1 year
Measured: Baseline and through study completion, an average of 1 year
Ocular biological measurements changes
Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance
Measured: Baseline and through study completion, an average of 1 year
Incidence changes of postoperative complications
Incidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on
Measured: Baseline and through study completion, an average of 1 year
Secondary outcomes (5)
Other factors changes
Sleep, depression, cognitive function are measured by questionnaires. Self-Rating Scale of Sleep: minimum value-1 point, maximum value-50, and higher scores mean worse outcome. Hamilton Depression Scale: <7 points-normal, and higher scores mean worse outcome. Loewenstein Cognitive Assessment: for every question, minimum 1 point, and maximum 4 points. Higher scores mean worse outcomes.
Measured: Baseline and through study completion, an average of 1 year
BMI changes
BMI is measured by technicians in every visit
Measured: Baseline and through study completion, an average of 1 year
Blood pressure changes
Diastolic and systolic blood pressure are measured by technicians in every visit
Measured: Baseline and through study completion, an average of 1 year
Stereopsis changes
Stereopsis is measured by Randot Stereotest
Measured: Baseline and through study completion, an average of 1 year
Optical coherence tomography (OCT) changes
Retinal thickness is measured and analyzed by OCT
Measured: Baseline and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start22 Aug 2022
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric CataractStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Yizhi Liu, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472844
- Sponsor's protocol ID
- 2022KYPJ099
- Status last verified
- Sep 2022
- First submitted
- 6 Jun 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solebo AL, Teoh L, Rahi J. Epidemiology of blindness in children. Arch Dis Child. 2017 Sep;102(9):853-857. doi: 10.1136/archdischild-2016-310532. Epub 2017 May 2.
PubMed 28465303Chak M, Wade A, Rahi JS; British Congenital Cataract Interest Group. Long-term visual acuity and its predictors after surgery for congenital cataract: findings of the British congenital cataract study. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4262-9. doi: 10.1167/iovs.05-1160.
PubMed 17003414Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1.
PubMed 28539328
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cohort Study of Pediatric Cataract
- ClinicalTrials.gov ID
- NCT05472844
- Acronym / sponsor ID
- 2022KYPJ099
- Conditions
- Pediatric Cataract
- Keywords
- congenital cataract, traumatic cataract, complicated cataract, ocular structure parameters, surgical/vision recovery timing and strategies, postoperative adverse effects, psychologic and cognitive function, artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 25 Jul 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.
This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.
Detailed description
Pediatric cataract, one of the leading causes of childhood blindness globally, is complex and of great difficulty in treatment. Pediatric patients with cataract (congenital, traumatic or complicated) are enrolled. In this study, investigators will compare ocular parameter changes, different surgical/vision timing or recovery strategies and adverse effects among young children （age < 18 yo）before and after cataract surgery. The influence on psychology and cognitive function will be taken into consideration as well. The whole blood samples of participants and parents are collected and retained in our biobank for gene sequencing, hoping to explore the genetic factors in association with pathogenesis. For children received cataract surgery, samples of partial anterior capsular tissue and 1 ml aqueous humor were collected during operation for further analysis. Multimodal artificial intelligence analyses are performed to establish accurate diagnosis/treatment scheme and disease prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This is a retrospective-prospective bidirectional cohort study. Patients aged < 18 yo at the 1st visit are enrolled.
Key inclusion criteria (1 listed)
- aged < 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent
Key exclusion criteria (1 listed)
- adults
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
Best-corrected visual acuity changes
Time frame: Baseline and through study completion, an average of 1 year
Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time
Intraocular pressure changes
Time frame: Baseline and through study completion, an average of 1 year
Intraocular pressures are measured by NCT machine
Refractive power changes
Time frame: Baseline and through study completion, an average of 1 year
Refractive power are measured at baseline and every visit at least every 1 year
Ocular biological measurements changes
Time frame: Baseline and through study completion, an average of 1 year
Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance
Incidence changes of postoperative complications
Time frame: Baseline and through study completion, an average of 1 year
Incidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on
5 secondary outcomes
Other factors changes
Time frame: Baseline and through study completion, an average of 1 year
BMI changes
Time frame: Baseline and through study completion, an average of 1 year
Blood pressure changes
Time frame: Baseline and through study completion, an average of 1 year
Stereopsis changes
Time frame: Baseline and through study completion, an average of 1 year
Optical coherence tomography (OCT) changes
Time frame: Baseline and through study completion, an average of 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 27 Sep 2022.
- Background: PubMed 28465303Solebo AL, Teoh L, Rahi J. Epidemiology of blindness in children. Arch Dis Child. 2017 Sep;102(9):853-857. doi: 10.1136/archdischild-2016-310532. Epub 2017 May 2.
- Background: PubMed 17003414Chak M, Wade A, Rahi JS; British Congenital Cataract Interest Group. Long-term visual acuity and its predictors after surgery for congenital cataract: findings of the British congenital cataract study. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4262-9. doi: 10.1167/iovs.05-1160.
- Background: PubMed 28539328Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1.
- Individual participant dataSharing planned: No
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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.
Yizhi Liu, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Pediatric Cataract, 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 1 inclusion and 1 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 27 Sep 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?
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 Zhenzhen Liu, PhD (+020 66618932, liuzhenzhen@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity changes (time frame: Baseline and through study completion, an average of 1 year). The study lists 5 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 NCT05472844, which also lists 3 linked publications.
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 27 Sep 2022.