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.

Study Overview

• Status: Completed
• Conditions: Microcornea Within One Year of Age
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 313000
      • Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
horizontal diameter of the cornea	Use a ruler to measure during surgery	2015.5.1-2020.12.1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
age		2015.5.1-2020.12.1
Eye axis	A-type ultrasonic measuring instrument	2015.5.1-2020.12.1
intraocular pressure	i care handheld tonometer	2015.5.1-2020.12.1
steep axis of corneal curvature	Handheld eye curvature measuring instrument	2015.5.1-2020.12.1
flat axis of corneal curvature	Handheld eye curvature measuring instrument	2015.5.1-2020.12.1
corneal thickness	Handheld corneal thickness measuring instrument	2015.5.1-2020.12.1
lens thickness	A-type ultrasonic measuring instrument	2015.5.1-2020.12.1
anterior chamber depth	SS-OCT	2015.5.1-2020.12.1

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Publications and helpful links

General Publications

• Zhang H, Chen Z, He K, Chang P, Zhao Y, Huang X, Li J, Jin Z, Zhao YE. Unique presentation of congenital cataract concurrent with microcornea, microphthalmia plus posterior capsule defect in monozygotic twins caused by a novel GJA8 mutation. Eye (Lond). 2019 Apr;33(4):686-689. doi: 10.1038/s41433-018-0277-y. Epub 2018 Nov 29. No abstract available.
• Matalia J, Shirke S, Shetty KB, Matalia H. Surgical Outcome of Congenital Cataract in Eyes With Microcornea. J Pediatr Ophthalmol Strabismus. 2018 Jan 1;55(1):30-36. doi: 10.3928/01913913-20170703-13. Epub 2017 Oct 9.
• Liu T, Zhang M, Xu B, Wang W, Lee J, Gao Y, Zhang X. Evaluation of the safety of sclerotomy incision in patients with choroidal colobomas with/without associated microcornea. Retina. 2014 Nov;34(11):2300-5. doi: 10.1097/IAE.0000000000000227.

Helpful Links

• Evaluation of the safety of sclerotomy incision in patients with choroidal colobomas with/without associated microcornea
• Surgical Outcome of Congenital Cataract in Eyes With Microcornea. J Pediatr Ophthalmol Strabismus.
• Unique presentation of congenital cataract concurrent with microcornea, microphthalmia plus posterior capsule defect in monozygotic twins caused by a novel GJA8 mutation.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Microcornea

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No