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NCT05451745Active, not recruiting

Glaucoma Following Pediatric Cataract Surgery

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

Source: ClinicalTrials.gov · Last updated 11 Jul 2022

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
819 (actual)
First submitted
26 Jun 2022
Start date
Jan 2011
Primary completion date
Jan 2022
Lead sponsor
Sun Yat-sen University
Diseases
Glaucoma
NCT number
NCT05451745

What you commit to

  • Study type: Observational
  • Participants enrolled: 819
  • From Jan 2011 to the primary completion date, Jan 2022
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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

Age

  • 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.

Other

  • 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.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 3 months to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.