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Completed

NCT Number: NCT04852341

Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old

This subject is mainly to study difference of Congenital cataract preoperative related parameters in children with or without Microcornea within Less than one year old. A total of 186 eyes of 117 people were collected with relevant ocular biological parameters, including age, horizontal diameter of the cornea, Eye axis, intraocular pressure, steep axis of corneal curvature, flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth. At present, because the definition of patients with small cornea is not clear enough, the study subjects are divided into 4 groups according to the horizontal corneal diameter of 9.0mm, 9.5mm, and 10.0mm, namely ≤9.0mm group, 9~9.5mm group, 9.5~10.0mm group and The >10.0mm group compares the differences between each other, and tries to provide a reference for the diagnosis of children with small cornea at a young age.

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Key information

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Wenzhou Medical University

Hangzhou, Zhejiang, 313000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Congenital cataract children with or without Microcornea within Less than one year old
  • Complete collection of eye biological parameters before the first-stage Congenital cataract surgery
  • The nutritional status and development of the included subjects have no obvious defects

Exclusion criteria

  • congenital persistent pupilary membrane
  • lens sublaxation or lens dislocotion
  • Marfan syndrome
  • Down's Syndrome
  • Peters abnormality
  • Fevr
  • history of obvious eye trauma
  • obvious macula
  • long-term (local or systemic) use of glucocorticoids.

Treatment and study plan

Collect ocular biological parameters including age, corneal diameter, eye axis, intraocular pressure, steep&flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth

Device

observation

Primary outcomes

  1. horizontal diameter of the cornea

    Time frame: 2015.5.1-2020.12.1

    Use a ruler to measure during surgery

Secondary outcomes

  1. age

    Time frame: 2015.5.1-2020.12.1

  2. Eye axis

    Time frame: 2015.5.1-2020.12.1

    A-type ultrasonic measuring instrument

  3. intraocular pressure

    Time frame: 2015.5.1-2020.12.1

    i care handheld tonometer

  4. steep axis of corneal curvature

    Time frame: 2015.5.1-2020.12.1

    Handheld eye curvature measuring instrument

  5. flat axis of corneal curvature

    Time frame: 2015.5.1-2020.12.1

    Handheld eye curvature measuring instrument

  6. corneal thickness

    Time frame: 2015.5.1-2020.12.1

    Handheld corneal thickness measuring instrument

  7. lens thickness

    Time frame: 2015.5.1-2020.12.1

    A-type ultrasonic measuring instrument

  8. anterior chamber depth

    Time frame: 2015.5.1-2020.12.1

    SS-OCT

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.