GlaucomaNCT04342052
Glaucoma After Congenital Cataract Surgery
An observational study of Glaucoma and Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Glaucoma, Congenital Cataract
- How many people
- 351 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 31 Dec 2024
- 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
- No healthy volunteers
- Child, Adult
Study population: A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital cataracts was performed.
Who may be able to join
- a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies;
- cataract surgery performed in ZOC;
- age at cataract removal younger than 16 years;
Who cannot join
- the preoperative IOP was above 21 mm Hg;
- family history of glaucoma;
- signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift;
- ocular trauma history;
- previous surgery intervention and
- they were noncompliant with our follow-up protocol to monitor the occurrence of glaucoma and glaucoma suspect.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 510000
About this study
To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.
Read the detailed description
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.
- Conditions
- Glaucoma, Congenital Cataract
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of glaucoma after congenital cataract surgery
A Kaplan-Meier analysis was used
Measured: baseline
Secondary outcomes (1)
Risk factors of glaucoma after congenital cataract surgery
Piecewise exponential survival models with mixed effects (PEWSMME) were used.(variables including demographic characters, surgery categories, clinical history, length of follow up).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Jan 2011
- Primary completion8 Apr 2020
- Study completion31 Dec 2024 (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 GlaucomaStudies of the same condition, open and under way.
- More trials run by 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
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342052
- Sponsor's protocol ID
- CCPMOH2020
- Status last verified
- May 2021
- First submitted
- 7 Apr 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Wu X, Wang Q, Zhou F, Chen H, Chen W, Lin D, Zhang X, Wang R, Chen J, Liu Z, Lin Z, Li X, Li J, Han Y, Liu Y, Lin H, Chen W. Incidence of and risk factors for suspected and definitive glaucoma after bilateral congenital cataract surgery: a 5-year follow-up. Br J Ophthalmol. 2024 Feb 21;108(3):476-483. doi: 10.1136/bjo-2022-322589.
PubMed 36828619
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma After Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT04342052
- Acronym / sponsor ID
- CCPMOH2020
- Conditions
- Glaucoma, Congenital Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Apr 2020 (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.
To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.
Detailed description
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.
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
- A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital cataracts was performed.
Key inclusion criteria (3 listed)
- a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies;
- cataract surgery performed in ZOC;
- age at cataract removal younger than 16 years;
Key exclusion criteria (6 listed)
- the preoperative IOP was above 21 mm Hg;
- family history of glaucoma;
- signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift;
- ocular trauma history;
- previous surgery intervention and
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
the incidence of glaucoma after congenital cataract surgery
Time frame: baseline
A Kaplan-Meier analysis was used
1 secondary outcome
Risk factors of glaucoma after congenital cataract surgery
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 36828619Wang J, Wu X, Wang Q, Zhou F, Chen H, Chen W, Lin D, Zhang X, Wang R, Chen J, Liu Z, Lin Z, Li X, Li J, Han Y, Liu Y, Lin H, Chen W. Incidence of and risk factors for suspected and definitive glaucoma after bilateral congenital cataract surgery: a 5-year follow-up. Br J Ophthalmol. 2024 Feb 21;108(3):476-483. doi: 10.1136/bjo-2022-322589.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glaucoma and Congenital Cataract, run by 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 3 inclusion and 6 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 1 Jun 2021. 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?
Results are not available in the source record.
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?
the incidence of glaucoma after congenital cataract surgery (time frame: baseline). 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 NCT04342052, 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 1 Jun 2021.