Capsular Contracture, ImplantcapsularNCT04803097
Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation
An observational study of Capsular Contracture, Implant and Pediatric Cataract, run by Yune Zhao at 1 site in China.
Trial summary
Lens capsular often changes after pediatric cataract surgery，causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. Read more about this study
- Who is it for?
- Ages 6 to 96 months
- Conditions the study is for
- Capsular Contracture, Implant, Pediatric Cataract
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 1 Jan 2020
- 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 6 to 96 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients （age：0.5~8.0 years）with congenital cataract
Who may be able to join
- Children (age 0.5~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.
Who cannot join
- Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens
Lens capsular often changes after pediatric cataract surgery，causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.
Read the detailed description
To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.
- Conditions
- Capsular Contracture, Implant, Pediatric Cataract
- Keywords
- capsular outcome, pediatric cataract, posterior capsulorhexis
- Medical subject headings
- Implant Capsular Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test
We took slit-lamp-adapted anterior segmental photography from pediatric cataract eyes at baseline，1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| pediatric cataract group | Children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China) between 2016 and 2019 were included in the study. Every surgery included posterior capsulorhexis or capsulotomy and anterior vitrectomy. Patients accept slit-lamp-adapted anterior segmental photography at 1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCOA
A comparison of posterior capsular opening areas at the corresponding time points
Measured: 20.74 ± 7.89 months
VATA
A comparison of visual axis transparent areas at the corresponding time points
Measured: 20.74 ± 7.89 months
Secondary outcomes (1)
axial length growth
The growth of axial length at the corresponding time points
Measured: 20.74 ± 7.89 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jun 2016
- Primary completion1 Jun 2019
- Study completion1 Jan 2020
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 Capsular Contracture, ImplantStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803097
- Sponsor's protocol ID
- cataract- fuyana
- Acronym
- capsular
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin H, Tan X, Lin Z, Chen J, Luo L, Wu X, Long E, Chen W, Liu Y. Capsular Outcomes Differ with Capsulorhexis Sizes after Pediatric Cataract Surgery: A Randomized Controlled Trial. Sci Rep. 2015 Nov 5;5:16227. doi: 10.1038/srep16227.
PubMed 26537991Tan X, Lin H, Lin Z, Chen J, Tang X, Luo L, Chen W, Liu Y. Capsular Outcomes After Pediatric Cataract Surgery Without Intraocular Lens Implantation: Qualitative Classification and Quantitative Measurement. Medicine (Baltimore). 2016 Mar;95(10):e2993. doi: 10.1097/MD.0000000000002993.
PubMed 26962807Fu Y, Wang D, Ding X, Chang P, Zhao Y, Hu M, Li Z, Zhao YE. Posterior Capsular Outcomes of Pediatric Cataract Surgery With In-The-Bag Intraocular Lens Implantation. Front Pediatr. 2022 Apr 8;10:827084. doi: 10.3389/fped.2022.827084. eCollection 2022.
PubMed 35463896
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens
- ClinicalTrials.gov ID
- NCT04803097
- Acronym / sponsor ID
- capsular / cataract- fuyana
- Conditions
- Capsular Contracture, Implant, Pediatric Cataract
- Keywords
- capsular outcome, pediatric cataract, posterior capsulorhexis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Mar 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.
Lens capsular often changes after pediatric cataract surgery，causing complications such as anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so on. The aim of study was to prospectively investigate the capsular outcomes of pediatric cataract surgery with primary intraocular lens (IOL) implantation.
Detailed description
To investigate the capsular outcomes from a case series of children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at those time points, and analysis the correlations between the PCO area and influential factors, such as age at surgery, axial growth, and follow-up duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric cataract group | – | –Children who underwent cataract surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China) between 2016 and 2019 were included in the study. Every surgery included posterior capsulorhexis or capsulotomy and anterior vitrectomy. Patients accept slit-lamp-adapted anterior segmental photography at 1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively. |
Who may qualify
- Ages
- 6 to 96 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients （age：0.5~8.0 years）with congenital cataract
Key inclusion criteria (1 listed)
- Children (age 0.5~8 years) who underwent cataract surgery, posterior capsulorhexis or capsulotomy and anterior vitrectomyand primary IOL implantation at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). The follow-up period was at least 1 year.
Key exclusion criteria (1 listed)
- Patients with ocular trauma, corneal disorders, glaucoma, preoperative lens luxation or subluxation, membranous cataract, persistent hyperplastic primary vitreous, surgical or postoperative complications such as glaucoma or suspect-glaucoma and synechia, pupils that could not be sufficiently dilated, and those who could not complete follow-ups or did not have clear digital photographs.
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 |
|---|---|---|
| We took slit-lamp-adapted anterior segmental photography from pediatric cataract eyes at baseline，1 week, 2 weeks, 1 month, 3 months, and 6 months postoperatively. | Diagnostic test | pediatric cataract group |
Primary outcome
PCOA
Time frame: 20.74 ± 7.89 months
A comparison of posterior capsular opening areas at the corresponding time points
VATA
Time frame: 20.74 ± 7.89 months
A comparison of visual axis transparent areas at the corresponding time points
1 secondary outcome
axial length growth
Time frame: 20.74 ± 7.89 months
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 17 Mar 2021.
- Background: PubMed 26537991Lin H, Tan X, Lin Z, Chen J, Luo L, Wu X, Long E, Chen W, Liu Y. Capsular Outcomes Differ with Capsulorhexis Sizes after Pediatric Cataract Surgery: A Randomized Controlled Trial. Sci Rep. 2015 Nov 5;5:16227. doi: 10.1038/srep16227.
- Background: PubMed 26962807Tan X, Lin H, Lin Z, Chen J, Tang X, Luo L, Chen W, Liu Y. Capsular Outcomes After Pediatric Cataract Surgery Without Intraocular Lens Implantation: Qualitative Classification and Quantitative Measurement. Medicine (Baltimore). 2016 Mar;95(10):e2993. doi: 10.1097/MD.0000000000002993.
- Derived from this study: PubMed 35463896Fu Y, Wang D, Ding X, Chang P, Zhao Y, Hu M, Li Z, Zhao YE. Posterior Capsular Outcomes of Pediatric Cataract Surgery With In-The-Bag Intraocular Lens Implantation. Front Pediatr. 2022 Apr 8;10:827084. doi: 10.3389/fped.2022.827084. eCollection 2022.
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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 Capsular Contracture, Implant and Pediatric Cataract, run by Yune Zhao 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 17 Mar 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?
PCOA (time frame: 20.74 ± 7.89 months). 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?
On the ClinicalTrials.gov record for NCT04803097, 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 17 Mar 2021.