Congenital CataractNCT04427748
Electrophysiology in Congenital Cataract After Lensectomy and Anterior
An observational study of Congenital Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. Read more about this study
- Who is it for?
- Ages 18 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Cataract
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 3 Dec 2019
- 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 18 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: congenital cataract age from 1.5 years to 15 years who underwent cataract surgery at least 1 year
Who may be able to join
- phakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation
Who cannot join
- patients with mild cataracts do not require surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Change of Electrophysiology in Congenital Cataract After Lensectomy and Anterior Vitrectomy
In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and b-wave and PhNR related parameters was evaluated.
Read the detailed description
Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E).
electroretinography and photopic negative response are performed to each patient.The research was to evaluate the relationship between the best corrected visionn and the related parameters of a- and b-wave and PhNR .
- Conditions
- Congenital Cataract
- Keywords
- ERG
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 |
|---|---|---|
| congenital cataract group | children with congenital cataract who underwent lensectomy and anterior vitrectomy and IOL implantation are perfomed ERG | |
| age-matched normal children group | age-matched normal children are perfomed ERG |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERG
investigate retinal function changes of congenital cataract children. ERG related parameters including a- and b-wave and PhNR amplitude and latency.
Measured: at least 1year after the surgery of congenital cataract
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2018
- Primary completion12 Sep 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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-control
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427748
- Sponsor's protocol ID
- Electrophysiology-WJJ
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang J, Wang Y, Guan W, Zhao YE. Full-field electroretinogram recorded with skin electrodes in 6- to 12-year-old children. Doc Ophthalmol. 2023 Dec;147(3):179-188. doi: 10.1007/s10633-023-09944-9. Epub 2023 Aug 2.
PubMed 37530953
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of Electrophysiology in Congenital Cataract After Lensectomy and Anterior Vitrectomy
- ClinicalTrials.gov ID
- NCT04427748
- Acronym / sponsor ID
- Electrophysiology-WJJ
- Conditions
- Congenital Cataract
- Keywords
- ERG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 11 Jun 2020 (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.
In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and b-wave and PhNR related parameters was evaluated.
Detailed description
Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E).
electroretinography and photopic negative response are performed to each patient.The research was to evaluate the relationship between the best corrected visionn and the related parameters of a- and b-wave and PhNR .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| congenital cataract group | – | –children with congenital cataract who underwent lensectomy and anterior vitrectomy and IOL implantation are perfomed ERG |
| age-matched normal children group | – | –age-matched normal children are perfomed ERG |
Who may qualify
- Ages
- 18 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- congenital cataract age from 1.5 years to 15 years who underwent cataract surgery at least 1 year
Key inclusion criteria (1 listed)
- phakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation
Key exclusion criteria (1 listed)
- patients with mild cataracts do not require surgery
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
ERG
Time frame: at least 1year after the surgery of congenital cataract
investigate retinal function changes of congenital cataract children. ERG related parameters including a- and b-wave and PhNR amplitude and latency.
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 11 Jun 2020.
- Derived from this study: PubMed 37530953Wang J, Wang Y, Guan W, Zhao YE. Full-field electroretinogram recorded with skin electrodes in 6- to 12-year-old children. Doc Ophthalmol. 2023 Dec;147(3):179-188. doi: 10.1007/s10633-023-09944-9. Epub 2023 Aug 2.
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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.
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 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 1 inclusion and 1 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 11 Jun 2020. 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?
ERG (time frame: at least 1year after the surgery of congenital cataract). 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 NCT04427748, which also lists 1 linked publication.
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 11 Jun 2020.