Congenital CataractNCT04976608
Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery
An observational study of Congenital Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
To evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure. Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Congenital Cataract
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2021to 30 Dec 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 4 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with congenital cataract and were informed about their inclusion in the study and provided written consent.
Who may be able to join
- age of 4-60 years
- Congenital cataract surgery is planned
- The operation was successful without any complications
- Can cooperate well with OCT and MRI examinations
Who cannot join
- Intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases
- Behavioral, cognitive impairment
- Developmental delay
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang
Zhangliang Li, 13968832833, lizhangliang0328@126.com
About this study
To evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure.
Read the detailed description
According to the visual acuity after congenital cataract surgery, 30 patients are divided into 3 groups.SD-OCT and MRI were used to measure the parameters of the retina and the visual cortex, to compare the differences between different groups, and to analyze the relationship between the structure of the retina and the visual cortex and visual acuity.
- Conditions
- Congenital Cataract
- Keywords
- amblyopia, MRI, SD-OCT, visual acuity, retinal structure, visual cortex structure
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The BCVA of eyes is greater than 0.6 | |
| Group 2 | The BCVA of eyes is from 0.1 to 0.6 | |
| Group 3 | The BCVA of eyes is less than 0.6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness
Scan the 3.0mm diameter ETDRS ring area in the macular area with SD-OCT.
Measured: 2021.12.30
Subfoveal choroidal thickness
Scan the Subfoveal choroid in enhanced scan mode with SD-OCT.
Measured: 2021.12.30
Retinal nerve fiber layer thickness
Scan concentric circles with a length of 3.4mm and a diameter ranging from 2.5mm to 4.0mm in 12 directions centered on the optic disc with SD-OCT.
Measured: 2021.12.30
The volume of the lateral geniculate body
Measure the volume of the lateral geniculate body by T1 phase scan of MRI
Measured: 2021.12.30
The volume of the brodmann 17,18,19 area
Masure the volume of the brodmann 17,18,19 area by T1 phase scan of MRI
Measured: 2021.12.30
The FA of the white matter fiber bundle
Measure the Fraction Anisotropy of the white matter fiber bundle related to visual signal transduction by DWI scan of MRI
Measured: 2021.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start16 Jun 2021
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
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 Congenital CataractStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976608
- Sponsor's protocol ID
- amblyopia-LZL
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu L, Li Q, Zhang L, Tang S, Yang X, Liu L, Sweeney JA, Gong Q, Huang X. Altered cortical morphology of visual cortex in adults with monocular amblyopia. J Magn Reson Imaging. 2019 Nov;50(5):1405-1412. doi: 10.1002/jmri.26708. Epub 2019 Mar 10.
PubMed 30854758Allen B, Schmitt MA, Kushner BJ, Rokers B. Retinothalamic White Matter Abnormalities in Amblyopia. Invest Ophthalmol Vis Sci. 2018 Feb 1;59(2):921-929. doi: 10.1167/iovs.17-22930.
PubMed 29450539Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1.
PubMed 28539328
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Retinal and Visual Cortex Structure and Visual Acuity After Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT04976608
- Acronym / sponsor ID
- amblyopia-LZL
- Conditions
- Congenital Cataract
- Keywords
- amblyopia, MRI, SD-OCT, visual acuity, retinal structure, visual cortex structure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Jul 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.
To evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure.
Detailed description
According to the visual acuity after congenital cataract surgery, 30 patients are divided into 3 groups.SD-OCT and MRI were used to measure the parameters of the retina and the visual cortex, to compare the differences between different groups, and to analyze the relationship between the structure of the retina and the visual cortex and visual acuity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –The BCVA of eyes is greater than 0.6 |
| Group 2 | – | –The BCVA of eyes is from 0.1 to 0.6 |
| Group 3 | – | –The BCVA of eyes is less than 0.6 |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with congenital cataract and were informed about their inclusion in the study and provided written consent.
Key inclusion criteria (4 listed)
- age of 4-60 years
- Congenital cataract surgery is planned
- The operation was successful without any complications
- Can cooperate well with OCT and MRI examinations
Key exclusion criteria (3 listed)
- Intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases
- Behavioral, cognitive impairment
- Developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Macular thickness
Time frame: 2021.12.30
Scan the 3.0mm diameter ETDRS ring area in the macular area with SD-OCT.
Subfoveal choroidal thickness
Time frame: 2021.12.30
Scan the Subfoveal choroid in enhanced scan mode with SD-OCT.
Retinal nerve fiber layer thickness
Time frame: 2021.12.30
Scan concentric circles with a length of 3.4mm and a diameter ranging from 2.5mm to 4.0mm in 12 directions centered on the optic disc with SD-OCT.
The volume of the lateral geniculate body
Time frame: 2021.12.30
Measure the volume of the lateral geniculate body by T1 phase scan of MRI
The volume of the brodmann 17,18,19 area
Time frame: 2021.12.30
Masure the volume of the brodmann 17,18,19 area by T1 phase scan of MRI
The FA of the white matter fiber bundle
Time frame: 2021.12.30
Measure the Fraction Anisotropy of the white matter fiber bundle related to visual signal transduction by DWI scan of MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Background: PubMed 30854758Lu L, Li Q, Zhang L, Tang S, Yang X, Liu L, Sweeney JA, Gong Q, Huang X. Altered cortical morphology of visual cortex in adults with monocular amblyopia. J Magn Reson Imaging. 2019 Nov;50(5):1405-1412. doi: 10.1002/jmri.26708. Epub 2019 Mar 10.
- Background: PubMed 29450539Allen B, Schmitt MA, Kushner BJ, Rokers B. Retinothalamic White Matter Abnormalities in Amblyopia. Invest Ophthalmol Vis Sci. 2018 Feb 1;59(2):921-929. doi: 10.1167/iovs.17-22930.
- Background: PubMed 28539328Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1.
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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.
Yune Zhao study director
Ophthalmology and Optometry Hospital
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 Congenital Cataract, 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yune Zhao (8613819707056, zyehzeye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular thickness (time frame: 2021.12.30). The study lists 6 primary outcomes in all. 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 NCT04976608, 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 26 Jul 2021.