Glaucoma Following Pediatric Cataract Surgery

NCT05451745 | Active Not Recruiting DMC

• 1 other identifier: CCMPOH2022
• Study Type: observational
• Target: 819
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glaucoma Following Pediatric Cataract Surgery; Glaucoma Secondary; Congenital Cataract

Keywords

Pediatric Cataract; Congenital Cataract; Glaucoma following cataract surgery

Outcome Measures

Primary Outcomes (2)

• Incidence of glaucoma following congenital cataracts

  A Kaplan-Meier analysis was used.

  up to 10 years

• Risk factors of glaucoma following cataract surgery

  To use Cox regression analysis to evaluate the potential risk factors in GFCS.

  up to 10 years

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \) The guardian of the child voluntarily signed the informed consent;
• \) The age is ≤18 years old, and the gender is not limited;
• \) The diagnostic criteria for congenital cataract are met; the lens is opacified in one or both eyes;
• \) 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);
• \) 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.;
• \) The child has no family history of glaucoma;
• \) Cataract extraction was performed in our hospital, and/or no intraocular lens was implanted;
• \) Clinical diagnosis of glaucoma following cataract surgery
• \) The postoperative follow-up time was not less than 60 months.

You may not qualify if:

• \) Have received other eye surgery before enrollment, including cataract surgery, anti-glaucoma surgery, and corneal surgery, etc.;
• \) 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
• \) 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).
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related 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.

  PMID: 23922832 BACKGROUND

• 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.

  PMID: 31688374 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 11, 2022
• Study Start: January 1, 2011
• Primary Completion: January 1, 2022
• Study Completion (Estimated): January 1, 2032
• Last Updated: July 11, 2022

Record last verified: 2022-07