GlaucomaNCT04131114
Glaucoma After Congenital And Infantile Cataract Surgery
An observational study of Glaucoma and Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard… Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Glaucoma, Congenital Cataract
- How many people
- 241 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to Dec 2021
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2016 was performed.
Who may be able to join
- a diagnosis of congenital/infantile cataracts without any surgical intervention;
- age younger than 10 years;
- cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment
Who cannot join
- a preoperative IOP above 21 mm Hg;
- the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
- the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000
Jinghui Wang, Ph.D, +86-020-87333271, wangjinghui1106@163.com
About this study
Official title: Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China
Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.
Read the detailed description
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 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 suspected glaucoma/glaucoma after congenital cataracts
A Kaplan-Meier analysis was used.
Measured: 3 years
Risk Factors of suspected glaucoma/glaucoma after congenital cataracts
Cox regression analysis was assessed
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Jan 2011
- Primary completion30 Dec 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 241 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
- NCT04131114
- Sponsor's protocol ID
- CCPMOH2016-China-0303
- Status last verified
- Apr 2020
- First submitted
- 15 Oct 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China
- ClinicalTrials.gov ID
- NCT04131114
- Acronym / sponsor ID
- CCPMOH2016-China-0303
- Conditions
- Glaucoma, Congenital Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Oct 2019 (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.
Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.
Detailed description
A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2016 was performed.
Key inclusion criteria (3 listed)
- a diagnosis of congenital/infantile cataracts without any surgical intervention;
- age younger than 10 years;
- cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment
Key exclusion criteria (3 listed)
- a preoperative IOP above 21 mm Hg;
- the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
- the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.
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 suspected glaucoma/glaucoma after congenital cataracts
Time frame: 3 years
A Kaplan-Meier analysis was used.
Risk Factors of suspected glaucoma/glaucoma after congenital cataracts
Time frame: 3 years
Cox regression analysis was assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- 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. This study is not recruiting at the moment.
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 3 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 9 Apr 2020. 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?
Contact Haotian Lin, Ph.D (+86-020-87333271, gddlht@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of suspected glaucoma/glaucoma after congenital cataracts (time frame: 3 years). 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?
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 Apr 2020.