Clinical trial NCT04852341: Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old
Official title: Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microcornea Within One Year of Age
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 117
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: horizontal diameter of the cornea
timeFrame: 2015.5.1-2020.12.1
Secondary outcomes:
measure: age
timeFrame: 2015.5.1-2020.12.1
measure: Eye axis
timeFrame: 2015.5.1-2020.12.1
measure: intraocular pressure
timeFrame: 2015.5.1-2020.12.1
measure: steep axis of corneal curvature
timeFrame: 2015.5.1-2020.12.1
measure: flat axis of corneal curvature
timeFrame: 2015.5.1-2020.12.1
measure: corneal thickness
timeFrame: 2015.5.1-2020.12.1
measure: lens thickness
timeFrame: 2015.5.1-2020.12.1
measure: anterior chamber depth
timeFrame: 2015.5.1-2020.12.1
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.