Intraocular Inflammation in ChildrenNCT03472781
Demographics and Clinical Characteristics of Paediatric Intraocular Inflammation in Singapore
An observational study of Intraocular Inflammation in Children, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved and analyzed from… Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Intraocular Inflammation in Children
- How many people
- 75 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2017to Mar 2019
- 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 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 16 years and below diagnosed with intraocular inflammation in years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017
Who may be able to join
- Children aged 16 years and below
- Clinical diagnosis of intraocular inflammation
Who cannot join
- •Children with ocular conditions other than intraocular inflammation.
Trial locations and contacts
1 site in 1 country.
About this study
Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved and analyzed from the uveitis database retrospectively.
The results will be compared with other published studies on different study populations.
Read the detailed description
Data on demographics, etiology, clinical features, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved from the uveitis database retrospectively.
Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes will be analyzed using statistical software.
The results will be compared with other published studies on different study populations.
The results of this study will lead to an improved clinical practice with better treatment selections and an optimised monitoring protocol for follow up care for our paediatric patients with intraocular inflammation. This will lead to better clinical outcomes and prevention of serious sight threatening complications.
- Conditions
- Intraocular Inflammation in Children
- Being tested
- No intervention. A retrospective case review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. A retrospective case reviewOther
No intervention. A retrospective case review on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre from January 1989 to January 2017.
| Study group | Role | What they receive |
|---|---|---|
| Children with intraocular inflammation | All children diagnosed with intraocular inflammation at Singapore National Eye center from from January 1989 to January 2017. Receives: Other: No intervention. A retrospective case review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics and clinical characteristics of pediatric intraocular inflammation
percentage of ethnic distribution, percentage of age distribution, percentage of etiology, percentage of clinical features, percentage of diagnosis, percentage of secondary complications, percentage of treatment, percentage of outcomes
Measured: January 1989 to January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Jan 2017
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Inflammation in ChildrenStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Samanthila Waduthantri, Singapore National Eye Centre
- Investigators
- Samanthila Waduthantri, Principal investigator, Singapore National Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472781
- Sponsor's protocol ID
- R1428/11/2017
- Status last verified
- Apr 2019
- First submitted
- 6 Dec 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no individual identifiable data retrieved from the database. The research data will be stored in a password protected access controlled personal computer in SNEC.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographics and Clinical Characteristics of Paediatric Intraocular Inflammation in Singapore
- ClinicalTrials.gov ID
- NCT03472781
- Acronym / sponsor ID
- R1428/11/2017
- Conditions
- Intraocular Inflammation in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Mar 2018 (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.
Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved and analyzed from the uveitis database retrospectively.
The results will be compared with other published studies on different study populations.
Detailed description
Data on demographics, etiology, clinical features, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017, will be retrieved from the uveitis database retrospectively.
Data on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes will be analyzed using statistical software.
The results will be compared with other published studies on different study populations.
The results of this study will lead to an improved clinical practice with better treatment selections and an optimised monitoring protocol for follow up care for our paediatric patients with intraocular inflammation. This will lead to better clinical outcomes and prevention of serious sight threatening complications.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with intraocular inflammation | – | Other: No intervention. A retrospective case reviewAll children diagnosed with intraocular inflammation at Singapore National Eye center from from January 1989 to January 2017. |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 16 years and below diagnosed with intraocular inflammation in years and below that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017
Key inclusion criteria (2 listed)
- Children aged 16 years and below
- Clinical diagnosis of intraocular inflammation
Key exclusion criteria (1 listed)
- •Children with ocular conditions other than intraocular inflammation.
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 |
|---|---|---|
| No intervention. A retrospective case reviewNo intervention. A retrospective case review on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre from January 1989 to January 2017. | Other | Children with intraocular inflammation |
Primary outcome
Demographics and clinical characteristics of pediatric intraocular inflammation
Time frame: January 1989 to January 2017
percentage of ethnic distribution, percentage of age distribution, percentage of etiology, percentage of clinical features, percentage of diagnosis, percentage of secondary complications, percentage of treatment, percentage of outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No. There will be no individual identifiable data retrieved from the database. The research data will be stored in a password protected access controlled personal computer in SNEC.
Related trials for Intraocular Inflammation in Children
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
RecruitingObservational study
A Study of Uveitis in Children <18 Years of Age
Uveitis
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Behçet Disease
RecruitingPhase 4
A Multicenter, Open-label Study on the Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis
Adult Non-infectious Uveitis
Active, not recruitingObservational study
UNICORNS: Uveitis in Childhood Prospective National Cohort Study
Uveitis
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.
Samanthila Waduthantri principal investigator
Singapore National Eye Center
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 Intraocular Inflammation in Children, run by Singapore National Eye Centre at 1 site in Singapore.
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 2 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: finished, as of the sponsor's last update on 4 Apr 2019. 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 Singapore. 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?
Demographics and clinical characteristics of pediatric intraocular inflammation (time frame: January 1989 to January 2017). 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 4 Apr 2019.