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

NCT ID: NCT04852341

Last Updated: 2021-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2021-01-01

Brief Summary

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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

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Conditions

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Microcornea Within One Year of Age

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type DEVICE

observation

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

Intervention Type DEVICE

observation

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

Intervention Type DEVICE

observation

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

Intervention Type DEVICE

observation

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Deputy Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wenzhou Medical University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30498267 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28991349 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25011027 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/25011027/

Evaluation of the safety of sclerotomy incision in patients with choroidal colobomas with/without associated microcornea

https://pubmed.ncbi.nlm.nih.gov/28991349/

Surgical Outcome of Congenital Cataract in Eyes With Microcornea. J Pediatr Ophthalmol Strabismus.

https://pubmed.ncbi.nlm.nih.gov/30498267/

Unique presentation of congenital cataract concurrent with microcornea, microphthalmia plus posterior capsule defect in monozygotic twins caused by a novel GJA8 mutation.

Other Identifiers

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Microcornea

Identifier Type: -

Identifier Source: org_study_id

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