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

Sponsor
Wenzhou Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04852341
Collaborator
(none)
117
1
68.1
1.7

Study Details

Study Description

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, 99.5mm group, 9.510.0mm 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 Phase
  • 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

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 :
Dec 1, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. horizontal diameter of the cornea [2015.5.1-2020.12.1]

    Use a ruler to measure during surgery

Secondary Outcome Measures

  1. age [2015.5.1-2020.12.1]

  2. Eye axis [2015.5.1-2020.12.1]

    A-type ultrasonic measuring instrument

  3. intraocular pressure [2015.5.1-2020.12.1]

    i care handheld tonometer

  4. steep axis of corneal curvature [2015.5.1-2020.12.1]

    Handheld eye curvature measuring instrument

  5. flat axis of corneal curvature [2015.5.1-2020.12.1]

    Handheld eye curvature measuring instrument

  6. corneal thickness [2015.5.1-2020.12.1]

    Handheld corneal thickness measuring instrument

  7. lens thickness [2015.5.1-2020.12.1]

    A-type ultrasonic measuring instrument

  8. anterior chamber depth [2015.5.1-2020.12.1]

    SS-OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Wenzhou Medical University Hangzhou Zhejiang China 313000

Sponsors and Collaborators

  • Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Yune Zhao, Deputy Dean, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT04852341
Other Study ID Numbers:
  • Microcornea
First Posted:
Apr 21, 2021
Last Update Posted:
Apr 21, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 21, 2021