Microcornea Within One Year of AgeNCT04852341
Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old
An observational study of Microcornea Within One Year of Age, run by Wenzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Microcornea Within One Year of Age
- What is being tested?
- 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
- Type of treatment
- Medical device
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2015to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- congenital persistent pupilary membrane
- lens sublaxation or lens dislocotion
- Marfan syndrome
- Down's Syndrome
- Peters abnormality
- Fevr
Show all 9Show fewer
- history of obvious eye trauma
- obvious macula
- long-term (local or systemic) use of glucocorticoids.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Microcornea Within One Year of Age
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect ocular biological parameters including age, corneal diameter, eye axis, intraocular pressure, steep&flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depthDevice
observation
| Study group | Role | What they receive |
|---|---|---|
| Corneal horizontal diameter ≤9.00mm group | Not described Receives: 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 | |
| Corneal horizontal diameter 9.00mm~9.50mm group | Not described Receives: 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 | |
| Corneal horizontal diameter 9.50mm~10.00mm group | Not described Receives: 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 | |
| Corneal horizontal diameter >10.00mm group | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
horizontal diameter of the cornea
Use a ruler to measure during surgery
Measured: 2015.5.1-2020.12.1
Secondary outcomes (8)
age
Measured: 2015.5.1-2020.12.1
Eye axis
A-type ultrasonic measuring instrument
Measured: 2015.5.1-2020.12.1
intraocular pressure
i care handheld tonometer
Measured: 2015.5.1-2020.12.1
steep axis of corneal curvature
Handheld eye curvature measuring instrument
Measured: 2015.5.1-2020.12.1
flat axis of corneal curvature
Handheld eye curvature measuring instrument
Measured: 2015.5.1-2020.12.1
corneal thickness
Handheld corneal thickness measuring instrument
Measured: 2015.5.1-2020.12.1
lens thickness
A-type ultrasonic measuring instrument
Measured: 2015.5.1-2020.12.1
anterior chamber depth
SS-OCT
Measured: 2015.5.1-2020.12.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 May 2015
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Microcornea Within One Year of AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852341
- Sponsor's protocol ID
- Microcornea
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30498267Matalia 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.
PubMed 28991349Liu 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.
PubMed 25011027
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Difference of Preoperative Related Parameters in Children With or Without Microcornea Within Less Than One Year Old
- ClinicalTrials.gov ID
- NCT04852341
- Acronym / sponsor ID
- Microcornea
- Conditions
- Microcornea Within One Year of Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- congenital persistent pupilary membrane
- lens sublaxation or lens dislocotion
- Marfan syndrome
- Down's Syndrome
- Peters abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect ocular biological parameters including age, corneal diameter, eye axis, intraocular pressure, steep&flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depthobservation | Device | Corneal horizontal diameter 9.00mm~9.50mm group, Corneal horizontal diameter 9.50mm~10.00mm group, Corneal horizontal diameter >10.00mm group, Corneal horizontal diameter ≤9.00mm group |
Primary outcome
horizontal diameter of the cornea
Time frame: 2015.5.1-2020.12.1
Use a ruler to measure during surgery
8 secondary outcomes
age
Time frame: 2015.5.1-2020.12.1
Eye axis
Time frame: 2015.5.1-2020.12.1
intraocular pressure
Time frame: 2015.5.1-2020.12.1
steep axis of corneal curvature
Time frame: 2015.5.1-2020.12.1
flat axis of corneal curvature
Time frame: 2015.5.1-2020.12.1
corneal thickness
Time frame: 2015.5.1-2020.12.1
lens thickness
Time frame: 2015.5.1-2020.12.1
anterior chamber depth
Time frame: 2015.5.1-2020.12.1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Background: PubMed 30498267Zhang 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.
- Background: PubMed 28991349Matalia 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.
- Background: PubMed 25011027Liu 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.
- Evaluation of the safety of sclerotomy incision in patients with choroidal colobomas with/without associated microcorneaLink provided by the sponsor.
- Surgical Outcome of Congenital Cataract in Eyes With Microcornea. J Pediatr Ophthalmol Strabismus.Link provided by the sponsor.
- Unique presentation of congenital cataract concurrent with microcornea, microphthalmia plus posterior capsule defect in monozygotic twins caused by a novel GJA8 mutation.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcornea Within One Year of Age, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
horizontal diameter of the cornea (time frame: 2015.5.1-2020.12.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04852341, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.