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

Completed

• Conditions: Microcornea Within One Year of Age
• Interventions: 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

• Registration Number: NCT04852341
• Lead Sponsor: Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-15
• Last Update Submitted: 2021-04-15
• Study First Posted: 2021-04-21
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Corneal horizontal diameter 9.50mm~10.00mm group	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	-
Corneal horizontal diameter ≤9.00mm group	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	-
Corneal horizontal diameter 9.00mm~9.50mm group	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	-
Corneal horizontal diameter >10.00mm group	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	-

Primary Outcome Measures

Name	Time	Method
horizontal diameter of the cornea	2015.5.1-2020.12.1	Use a ruler to measure during surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wenzhou Medical University; 🇨🇳 Hangzhou, Zhejiang, China