Glaucoma Following Pediatric Cataract Surgery

Congenital Cataract Clinical Trial

Official title:

Incidence of and Risk Factors for Glaucoma Following Pediatric Cataract Surgery: 10 Years Longitudinal Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05451745
• Other study ID #: CCMPOH2022
• Status: Active, not recruiting
• Start date: January 2011
• Est. completion date: January 2032

Study information

• Verified date: July 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 819
• Est. completion date: January 2032
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

• 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;

• 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.

Exclusion Criteria:

• 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

1. Intraocular pressure: >21 mmHg (investigator discretion on the method of measurement and if EUA (Examination Under Anesthesia) data alone is sufficient).

2. Visual fields: reproducible visual field defect that is consistent with glaucomatous optic neuropathy with no other observable reason for the visual field defect.

3. Axial length: progressive myopia or myopic shift with increased ocular dimensions that outpace normal growth.

4. 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.

5. 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.

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract
• Glaucoma
• Glaucoma Secondary

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

References & Publications (2)

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. — View Citation

Wang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of glaucoma following congenital cataracts	A Kaplan-Meier analysis was used.	up to 10 years
Primary	Risk factors of glaucoma following cataract surgery	To use Cox regression analysis to evaluate the potential risk factors in GFCS.	up to 10 years