Congenital CataractNCT05275764
Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract
An observational study of Congenital Cataract and Intraocular Lens Implantation, run by Wenzhou Medical University at 1 site in China.
Trial summary
Approximately 30 eyes with congenital cataract who underwent primary or secondary intraocular lens implantation surgery at Zhejiang Eye Hospital from March 2018 to December 2020 were enrolled. According to the implantation method of IOL, patients were devided into the optic capture group and the endocapsular group. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Congenital Cataract, Intraocular Lens Implantation, Optic Capture
- What is being tested?
- primary or secondary intraocular lens implantation surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2022
- 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 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with congenital cataracts who underwent primary or secondary intraocular lens implantation surgery at the Eye Hospital Affiliated to Wenzhou Medical University.
Who may be able to join
- Children aged 1 to 10 years diagnosed with congenital cataract
- underwent I / II IOL implantation in our hospital
- corneal diameter more than 9mm
- Good compliance
Who cannot join
- Patients with other ocular or systemic diseases
- patients whose IOL cannot be implanted in or after the capsule due to ocular conditions
- Children with a history of other ocular surgery
- Low compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
Dandan Wang, MD, 18258227706
About this study
Approximately 30 eyes with congenital cataract who underwent primary or secondary intraocular lens implantation surgery at Zhejiang Eye Hospital from March 2018 to December 2020 were enrolled. According to the implantation method of IOL, patients were devided into the optic capture group and the endocapsular group. And through the clinical parameters of postoperative best corrected visual acuity (BCVA), intraocular pressure (IOP), IOL position and whether appear visual axis opacity to compare the outcome of the 2 IOL implantation methods.
- Being tested
- primary or secondary intraocular lens implantation surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary or secondary intraocular lens implantation surgeryProcedure or surgery
primary or secondary intraocular lens implantation surgery
| Study group | Role | What they receive |
|---|---|---|
| optic capture group | IOL optic was captured through the posterior continuous curvilinear capsulorhexis Receives: Procedure: primary or secondary intraocular lens implantation surgery | |
| endocapsular group | IOL was placed in the bag Receives: Procedure: primary or secondary intraocular lens implantation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL position
The horizontal and vertical inclination of IOL
Measured: through study completion, an average of 1 year
BCVA
best corrected visual acuity
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Nov 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275764
- Sponsor's protocol ID
- WDD-optic capture
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract
- ClinicalTrials.gov ID
- NCT05275764
- Acronym / sponsor ID
- WDD-optic capture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Mar 2022 (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.
Approximately 30 eyes with congenital cataract who underwent primary or secondary intraocular lens implantation surgery at Zhejiang Eye Hospital from March 2018 to December 2020 were enrolled. According to the implantation method of IOL, patients were devided into the optic capture group and the endocapsular group. And through the clinical parameters of postoperative best corrected visual acuity (BCVA), intraocular pressure (IOP), IOL position and whether appear visual axis opacity to compare the outcome of the 2 IOL implantation methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optic capture group | – | Procedure: primary or secondary intraocular lens implantation surgeryIOL optic was captured through the posterior continuous curvilinear capsulorhexis |
| endocapsular group | – | Procedure: primary or secondary intraocular lens implantation surgeryIOL was placed in the bag |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with congenital cataracts who underwent primary or secondary intraocular lens implantation surgery at the Eye Hospital Affiliated to Wenzhou Medical University.
Key inclusion criteria (4 listed)
- Children aged 1 to 10 years diagnosed with congenital cataract
- underwent I / II IOL implantation in our hospital
- corneal diameter more than 9mm
- Good compliance
Key exclusion criteria (4 listed)
- Patients with other ocular or systemic diseases
- patients whose IOL cannot be implanted in or after the capsule due to ocular conditions
- Children with a history of other ocular surgery
- Low compliance
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 |
|---|---|---|
| primary or secondary intraocular lens implantation surgeryprimary or secondary intraocular lens implantation surgery | Procedure or surgery | endocapsular group, optic capture group |
Primary outcome
IOL position
Time frame: through study completion, an average of 1 year
The horizontal and vertical inclination of IOL
BCVA
Time frame: through study completion, an average of 1 year
best corrected visual acuity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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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.
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 and Intraocular Lens Implantation, 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 4 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 11 Mar 2022. 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 (18258227706, zyehzeye@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL position (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2022.