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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852341
Recruitment Status : Completed
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Yune Zhao, Wenzhou Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Microcornea Within One Year of Age Device: 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

Study Design
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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : January 1, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Corneal horizontal diameter ≤9.00mm group Device: 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
observation
Corneal horizontal diameter 9.00mm~9.50mm group Device: 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
observation
Corneal horizontal diameter 9.50mm~10.00mm group Device: 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
observation
Corneal horizontal diameter >10.00mm group Device: 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
observation


Outcome Measures
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Primary Outcome Measures :
  1. horizontal diameter of the cornea [ Time Frame: 2015.5.1-2020.12.1 ]
    Use a ruler to measure during surgery


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
From May 2015 to December 2020,Congenital cataract children with or without Microcornea within one year of age attending the Eye Optometry Hospital of Wenzhou Medical University
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852341


Locations
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China, Zhejiang
Wenzhou Medical University
Hangzhou, Zhejiang, China, 313000
Sponsors and Collaborators
Wenzhou Medical University
More Information
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Additional Information:

Publications:

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Responsible Party: Yune Zhao, Deputy Dean, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04852341    
Other Study ID Numbers: Microcornea
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No