Congenital CataractNCT03342794
Morphologic and Biometric Characteristics of Preexisting Posterior Capsule Defects in Congenital Cataracts During the First Year of Life
A study testing cataract surgery in people with Congenital Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
Few descriptive studies have focused on the anatomical parameters in patients with preexisting PCDs. The characteristics of cataract morphology and anatomical parameters in these patients remained unclear, when compared with CC patients with intact posterior capsule. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- cataract surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 1 Aug 2019
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- congenital cataract
Who cannot join
- incooperative to complete the preoperative examinations
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
zhao Yinying, PhD, 13957763247, ginger146@126.com
About this study
Few descriptive studies have focused on the anatomical parameters in patients with preexisting PCDs. The characteristics of cataract morphology and anatomical parameters in these patients remained unclear, when compared with CC patients with intact posterior capsule. We conduct the current study to compare the cataract morphology and preoperative parameters, including central corneal thickness, axial length, anterior chamber depth, lens thickness, corneal diameter, keratometry，dialated pupil diameter and intraocular pressure, between CC patients with preexisting PCDs and those with intact posterior capsule, and to explore potential risk factors for preexisting PCDs.
Read the detailed description
This retrospective study reviewed infants (≤1 years old) with CC who were undergoing cataract extraction without IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China. CC patients with preexisting PCDs were placed in Study group, while CC patients with intact posterior capsule were included as controls.
The preexisting PCD was diagnosed if signs of a sharply bordered defect or white dots on the posterior capsule and/or in the anterior vitreous were detected. The intraoperative diagnosis of preexisting PCD was confirmed when the signs were observed after uneventful aspiration of the lens cortex. Patients who were incooperative to complete the preoperative examinations were excluded.
All CC patients were divided into two groups according to integrity of posterior capsule. Patients with a confirmed preexisting PCD were placed into the PCD group. Others with intact posterior capsule were in the control group. The preoperative data including sex, age at surgery, laterality of disease, and accompanying ocular anomalies were collected.
For all the CC patients, the preoperative examinations were completed under sedation. Central corneal thickness was obtained by a handheld ultrasonic pachymeter (PachPen, Accutome, US). Axial length, anterior chamber depth, lens thickness and length of vitreous cavity were measured via an immersion A-scan (Axis nano, Quantel Medical, French). An experienced examiner repeated the measurement 10 times and the mean value was included. The keratometry values and intraocular pressure were gained by a handheld keratometer (HandyRef-K, NIDEK, Japan) and a handheld tonometer (Icare, Vantaa, Finland), respectively. Diameter of cornea and dilated pupil (dilated by tropicamide 0.5% and phenylephrine hydrochloride 0.5%) was measured just before surgery.
All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia. Bimanual irrigation/aspiration and 2-port 23G anterior vitrectomy were performed. Three ophthalmologists reviewed all surgical recordings. The integrity of posterior capsule was masked to them. Morphological characteristics of cataracts were documented before surgery. After removing opaque cortex and/or nucleus, the configuration of preexisting PCDs was described.
- Conditions
- Congenital Cataract
- Being tested
- cataract surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
To diagnose the preexisting posterior capsule defects in congenital cataracts after the cataracts are removed by surgery and observe the characteristics
| Study group | Role | What they receive |
|---|---|---|
| preexisting posterior capsule defects | Other | congenital cataracts with a preexisting posterior capsule defect Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
lens thickness measured by A-scan ultrasonography
lens thickness in congenital cataracts with either preexisting posterior capsule defects or intact posterior capsule will be measured by A-scan and compared.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Aug 2019 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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
- NCT03342794
- Sponsor's protocol ID
- PCD_HZ
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- 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 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphologic and Biometric Characteristics of Preexisting Posterior Capsule Defects in Congenital Cataracts During the First Year of Life
- ClinicalTrials.gov ID
- NCT03342794
- Acronym / sponsor ID
- PCD_HZ
- Conditions
- Congenital Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 17 Nov 2017 (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.
Few descriptive studies have focused on the anatomical parameters in patients with preexisting PCDs. The characteristics of cataract morphology and anatomical parameters in these patients remained unclear, when compared with CC patients with intact posterior capsule. We conduct the current study to compare the cataract morphology and preoperative parameters, including central corneal thickness, axial length, anterior chamber depth, lens thickness, corneal diameter, keratometry，dialated pupil diameter and intraocular pressure, between CC patients with preexisting PCDs and those with intact posterior capsule, and to explore potential risk factors for preexisting PCDs.
Detailed description
This retrospective study reviewed infants (≤1 years old) with CC who were undergoing cataract extraction without IOL implantation at the Eye Hospital of Wenzhou Medical University, Hangzhou, China. CC patients with preexisting PCDs were placed in Study group, while CC patients with intact posterior capsule were included as controls.
The preexisting PCD was diagnosed if signs of a sharply bordered defect or white dots on the posterior capsule and/or in the anterior vitreous were detected. The intraoperative diagnosis of preexisting PCD was confirmed when the signs were observed after uneventful aspiration of the lens cortex. Patients who were incooperative to complete the preoperative examinations were excluded.
All CC patients were divided into two groups according to integrity of posterior capsule. Patients with a confirmed preexisting PCD were placed into the PCD group. Others with intact posterior capsule were in the control group. The preoperative data including sex, age at surgery, laterality of disease, and accompanying ocular anomalies were collected.
For all the CC patients, the preoperative examinations were completed under sedation. Central corneal thickness was obtained by a handheld ultrasonic pachymeter (PachPen, Accutome, US). Axial length, anterior chamber depth, lens thickness and length of vitreous cavity were measured via an immersion A-scan (Axis nano, Quantel Medical, French). An experienced examiner repeated the measurement 10 times and the mean value was included. The keratometry values and intraocular pressure were gained by a handheld keratometer (HandyRef-K, NIDEK, Japan) and a handheld tonometer (Icare, Vantaa, Finland), respectively. Diameter of cornea and dilated pupil (dilated by tropicamide 0.5% and phenylephrine hydrochloride 0.5%) was measured just before surgery.
All surgeries were performed by the same surgeon (Y.E.Z.) under general anesthesia. Bimanual irrigation/aspiration and 2-port 23G anterior vitrectomy were performed. Three ophthalmologists reviewed all surgical recordings. The integrity of posterior capsule was masked to them. Morphological characteristics of cataracts were documented before surgery. After removing opaque cortex and/or nucleus, the configuration of preexisting PCDs was described.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preexisting posterior capsule defects | Other | Procedure: cataract surgerycongenital cataracts with a preexisting posterior capsule defect |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- congenital cataract
Key exclusion criteria (1 listed)
- incooperative to complete the preoperative examinations
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 |
|---|---|---|
| cataract surgeryTo diagnose the preexisting posterior capsule defects in congenital cataracts after the cataracts are removed by surgery and observe the characteristics | Procedure or surgery | preexisting posterior capsule defects |
Primary outcome
lens thickness measured by A-scan ultrasonography
Time frame: 6 months
lens thickness in congenital cataracts with either preexisting posterior capsule defects or intact posterior capsule will be measured by A-scan and compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- 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?
A study testing cataract surgery in people with 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: status not confirmed, as of the sponsor's last update on 17 Nov 2017. 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 Zhangliang Li, MD (86-571-88185666, lizhangliang0328@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lens thickness measured by A-scan ultrasonography (time frame: 6 months). 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 17 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.