Glaucoma Following Pediatric Cataract SurgeryNCT05451745
Glaucoma Following Pediatric Cataract Surgery
An observational study of Glaucoma Following Pediatric Cataract Surgery and Glaucoma Secondary, run by Sun Yat-sen University.
Trial summary
The purpose of this study is to report the incidence and related risk factors glaucoma following cataract surgery (GFCS). and to provide evidence-based evidence for the development of standardized follow-up methods or diagnosis and treatment decisions. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Glaucoma Following Pediatric Cataract Surgery, Glaucoma Secondary, Congenital Cataract
- How many people
- 819 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Relying on the congenital cataract research platform established by our hospital, this prospective cohort clinical study will prospectively register children with congenital cataracts who underwent cataract extraction in our hospital from January 2010 to December 2016.
Who may be able to join
- 1) The guardian of the child voluntarily signed the informed consent;
- 2) The age is ≤18 years old, and the gender is not limited;
- 3) The diagnostic criteria for congenital cataract are met; the lens is opacified in one or both eyes;
- 4) The intraocular pressure before cataract extraction is normal ( less than 21 mmHg, considering the errors caused by different intraocular pressure measurement methods and different anesthesia methods);
- 5) The children have no glaucoma-related clinical manifestations and signs before cataract extraction, such as large corneal diameter, corneal edema or opacity, Increased cup-to-disk ratio, etc.;
- 6) The child has no family history of glaucoma;
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- 7) Cataract extraction was performed in our hospital, and/or no intraocular lens was implanted;
- 9) Clinical diagnosis of glaucoma following cataract surgery
- 10) The postoperative follow-up time was not less than 60 months.
Who cannot join
- 1) Have received other eye surgery before enrollment, including cataract surgery, anti-glaucoma surgery, and corneal surgery, etc.;
- 2) Combined with congenital glaucoma, a clear history of eye trauma, and other complex eyes medical history (including persistent Persistent hyperplastic primary vitreous (PHPV), Peter's anomaly, congenital aniridia, Marfan syndrome, lens insufficiency, retinitis pigmentosa, high myopia, fundus lesions, congenital rubella syndrome, ocular brain-renal syndrome
- 3) Combined with other serious systemic diseases (cardiovascular, respiratory, digestive, urinary, nervous, and other system diseases)
- Clinical diagnosis of glaucoma following cataract surgery:
- after cataract removal, two or more of the following are required
- Intraocular pressure: >21 mmHg (investigator discretion on the method of measurement and if EUA (Examination Under Anesthesia) data alone is sufficient).
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- Visual fields: reproducible visual field defect that is consistent with glaucomatous optic neuropathy with no other observable reason for the visual field defect.
- Axial length: progressive myopia or myopic shift with increased ocular dimensions that outpace normal growth.
- Cornea: findings including Haab striae, corneal diameter >11mm in newborns, >12mm in children younger than 1 year old, and >13mm in children older than 1 year old.
- Optic nerve: progressive increase in the cup-disc ratio, cup-disc asymmetry of 0.2 when optic discs are of similar size, and focal rim thinning.
About this study
Official title: Incidence of and Risk Factors for Glaucoma Following Pediatric Cataract Surgery: 10 Years Longitudinal Study
The purpose of this study is to report the incidence and related risk factors glaucoma following cataract surgery (GFCS). and to provide evidence-based evidence for the development of standardized follow-up methods or diagnosis and treatment decisions.
Read the detailed description
A secondary clinical data analysis from a prospective longitudinal cohort study. A total of 819 children with congenital cataracts (CC) were included from January 2011 to December 2016, and the follow-up deadline was January 31, 2022. All study subjects were under 18 years old, and the average follow-up time after cataract extraction was over 5 years. The children were divided into subgroups according to whether the intraocular lens (IOL) was implanted or not after cataract surgery, and the clinical characteristics were compared. Cox regression analysis model and Kaplan-Meier survival analysis model were used to investigate the incidence, cumulative risk probability and related risk factors of GFCS events. A nomogram was used to build a predictive model for the occurrence of GFCS.
- Keywords
- Pediatric Cataract, Congenital Cataract, Glaucoma following cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of glaucoma following congenital cataracts
A Kaplan-Meier analysis was used.
Measured: up to 10 years
Risk factors of glaucoma following cataract surgery
To use Cox regression analysis to evaluate the potential risk factors in GFCS.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study startJan 2011
- Primary completionJan 2022
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glaucoma Following Pediatric Cataract SurgeryStudies 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
- 819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451745
- Sponsor's protocol ID
- CCMPOH2022
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin H, Chen W, Luo L, Zhang X, Chen J, Lin Z, Qu B, Zhan J, Zheng D, Zhong X, Tian Z, Liu Y; Study Group of CCPMOH. Ocular hypertension after pediatric cataract surgery: baseline characteristics and first-year report. PLoS One. 2013 Jul 29;8(7):e69867. doi: 10.1371/journal.pone.0069867. Print 2013.
PubMed 23922832Wang J, Chen J, Chen W, Wang Q, Zhao L, Wang R, Liu Z, Chen H, Cao Q, Tan X, Lin Z, Li X, Li J, Lai W, Zhu Y, Chen C, Zheng D, Wu M, Han Y, Chen W, Liu Y, Lin H. Incidence of and Risk Factors for Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China. J Glaucoma. 2020 Jan;29(1):46-52. doi: 10.1097/IJG.0000000000001398.
PubMed 31688374
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of and Risk Factors for Glaucoma Following Pediatric Cataract Surgery: 10 Years Longitudinal Study
- ClinicalTrials.gov ID
- NCT05451745
- Acronym / sponsor ID
- CCMPOH2022
- Keywords
- Pediatric Cataract, Congenital Cataract, Glaucoma following cataract surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 819 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2032 (estimated)
- First posted
- 11 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.
The purpose of this study is to report the incidence and related risk factors glaucoma following cataract surgery (GFCS). and to provide evidence-based evidence for the development of standardized follow-up methods or diagnosis and treatment decisions.
Detailed description
A secondary clinical data analysis from a prospective longitudinal cohort study. A total of 819 children with congenital cataracts (CC) were included from January 2011 to December 2016, and the follow-up deadline was January 31, 2022. All study subjects were under 18 years old, and the average follow-up time after cataract extraction was over 5 years. The children were divided into subgroups according to whether the intraocular lens (IOL) was implanted or not after cataract surgery, and the clinical characteristics were compared. Cox regression analysis model and Kaplan-Meier survival analysis model were used to investigate the incidence, cumulative risk probability and related risk factors of GFCS events. A nomogram was used to build a predictive model for the occurrence of GFCS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Relying on the congenital cataract research platform established by our hospital, this prospective cohort clinical study will prospectively register children with congenital cataracts who underwent cataract extraction in our hospital from January 2010 to December 2016.
Key inclusion criteria (9 listed)
- 1) The guardian of the child voluntarily signed the informed consent;
- 2) The age is ≤18 years old, and the gender is not limited;
- 3) The diagnostic criteria for congenital cataract are met; the lens is opacified in one or both eyes;
- 4) The intraocular pressure before cataract extraction is normal ( less than 21 mmHg, considering the errors caused by different intraocular pressure measurement methods and different anesthesia methods);
- 5) The children have no glaucoma-related clinical manifestations and signs before cataract extraction, such as large corneal diameter, corneal edema or opacity, Increased cup-to-disk ratio, etc.;
Key exclusion criteria (10 listed)
- 1) Have received other eye surgery before enrollment, including cataract surgery, anti-glaucoma surgery, and corneal surgery, etc.;
- 2) Combined with congenital glaucoma, a clear history of eye trauma, and other complex eyes medical history (including persistent Persistent hyperplastic primary vitreous (PHPV), Peter's anomaly, congenital aniridia, Marfan syndrome, lens insufficiency, retinitis pigmentosa, high myopia, fundus lesions, congenital rubella syndrome, ocular brain-renal syndrome
- 3) Combined with other serious systemic diseases (cardiovascular, respiratory, digestive, urinary, nervous, and other system diseases)
- after cataract removal, two or more of the following are required
- Intraocular pressure: >21 mmHg (investigator discretion on the method of measurement and if EUA (Examination Under Anesthesia) data alone is sufficient).
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
Incidence of glaucoma following congenital cataracts
Time frame: up to 10 years
A Kaplan-Meier analysis was used.
Risk factors of glaucoma following cataract surgery
Time frame: up to 10 years
To use Cox regression analysis to evaluate the potential risk factors in GFCS.
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 11 Jul 2022.
- Background: PubMed 23922832Lin H, Chen W, Luo L, Zhang X, Chen J, Lin Z, Qu B, Zhan J, Zheng D, Zhong X, Tian Z, Liu Y; Study Group of CCPMOH. Ocular hypertension after pediatric cataract surgery: baseline characteristics and first-year report. PLoS One. 2013 Jul 29;8(7):e69867. doi: 10.1371/journal.pone.0069867. Print 2013.
- Background: PubMed 31688374Wang J, Chen J, Chen W, Wang Q, Zhao L, Wang R, Liu Z, Chen H, Cao Q, Tan X, Lin Z, Li X, Li J, Lai W, Zhu Y, Chen C, Zheng D, Wu M, Han Y, Chen W, Liu Y, Lin H. Incidence of and Risk Factors for Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China. J Glaucoma. 2020 Jan;29(1):46-52. doi: 10.1097/IJG.0000000000001398.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Following Pediatric Cataract Surgery and Glaucoma Secondary, run by 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 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?
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?
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?
Incidence of glaucoma following congenital cataracts (time frame: up to 10 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?
On the ClinicalTrials.gov record for NCT05451745, which also lists 2 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 11 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.