CataractNCT02793869
A Novel Congenital Cataract Category System
An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cataract
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Dec 2015
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This was a prospective study and was included in our series of ongoing studies at the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH), a national project for congenital cataract (CC) treatment and research. CC patients less than 18 years old and seeking treatment at the ZOC, one of the best eye care facilities in China, from February 2011 to December 2015 were candidates for this study. All included participants were diagnosed with CC before surgery and lacked other ocular abnormalities, such as severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus. A total of 428 CC patients were included.
Who may be able to join
- Diagnosis of congenital cataract
- less than 18 years old
Who cannot join
- With other ocular abnormalities including severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: A Novel Congenital Cataract Category System Based on Lens Opacity Positions and Their Relevant Anterior Segment Characteristics
Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.
Read the detailed description
Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.
Using the largest CC database in the Zhongshan Ophthalmic Center (ZOC), the current study compared the anterior segment characteristics of CC patients with lens opacities in different positions and further proposed a modified CC category system based on the specific relationships between the position of lens opacities and anterior segment characteristics. Knowledge of these relationships is beneficial for further understanding of CC occurrence and development and has clinical significance for CC diagnosis and treatment.
- Conditions
- Cataract
- Keywords
- congenital cataract;anterior segment characteristics
- Medical subject headings
- Cataract
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 |
|---|---|---|
| Total cataract group | All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. | |
| Anterior cataract group | All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. | |
| Interior cataracts group | All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. | |
| Posterior cataract group | All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean keratometry value
The anterior segment parametersthe mean keratometry value of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.
Measured: Baseline
The central corneal thickness
The anterior segment parametersthe central corneal thickness of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.
Measured: Baseline
The anterior chamber depth
The anterior segment parametersthe anterior chamber depth of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startFeb 2011
- Primary completionDec 2015
- Study completionDec 2015
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 CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D., Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D., Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityWeirong Chen, M.D., Ph.D, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793869
- Sponsor's protocol ID
- CCPMOH2016-China-4
- Status last verified
- Jun 2016
- First submitted
- 3 Jun 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. No abstract available.
PubMed 26339020
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Congenital Cataract Category System Based on Lens Opacity Positions and Their Relevant Anterior Segment Characteristics
- ClinicalTrials.gov ID
- NCT02793869
- Acronym / sponsor ID
- CCPMOH2016-China-4
- Conditions
- Cataract
- Keywords
- congenital cataract;anterior segment characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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.
Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.
Detailed description
Congenital cataracts (CC) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. CC patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. Cataractous eyes of CC patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. Lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (CA). However, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of CC patients, a lack of proper equipment, and a lack of awareness of these important relationships.
Using the largest CC database in the Zhongshan Ophthalmic Center (ZOC), the current study compared the anterior segment characteristics of CC patients with lens opacities in different positions and further proposed a modified CC category system based on the specific relationships between the position of lens opacities and anterior segment characteristics. Knowledge of these relationships is beneficial for further understanding of CC occurrence and development and has clinical significance for CC diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total cataract group | – | –All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. |
| Anterior cataract group | – | –All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. |
| Interior cataracts group | – | –All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. |
| Posterior cataract group | – | –All selected eyes were categorized into four groups: total cataracts, anterior cataracts, interior cataracts and posterior cataracts, based on the position of lens opacities shown by both a slit lamp (BX900, HAAG-STREIT AG, Bern, Switzerland) examination and a 3-dimensional anterior segment imaging and analysis system (Pentacam HR, Oculus Inc., Wetzlar, Germany) after mydriasis. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This was a prospective study and was included in our series of ongoing studies at the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH), a national project for congenital cataract (CC) treatment and research. CC patients less than 18 years old and seeking treatment at the ZOC, one of the best eye care facilities in China, from February 2011 to December 2015 were candidates for this study. All included participants were diagnosed with CC before surgery and lacked other ocular abnormalities, such as severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus. A total of 428 CC patients were included.
Key inclusion criteria (2 listed)
- Diagnosis of congenital cataract
- less than 18 years old
Key exclusion criteria (1 listed)
- With other ocular abnormalities including severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus.
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
The mean keratometry value
Time frame: Baseline
The anterior segment parametersthe mean keratometry value of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.
The central corneal thickness
Time frame: Baseline
The anterior segment parametersthe central corneal thickness of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.
The anterior chamber depth
Time frame: Baseline
The anterior segment parametersthe anterior chamber depth of CC patients were measured by the 3-dimensional anterior segment imaging analysis system.
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 8 Jun 2016.
- Background: PubMed 26339020Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. No abstract available.
- Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
- Homepage of Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH)Link provided by the sponsor.
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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.
Haotian Lin, M.D., Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D., Ph.D study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Cataract, run by Sun Yat-sen 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 2 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 8 Jun 2016. 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?
The mean keratometry value (time frame: Baseline). The study lists 3 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 NCT02793869, 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 8 Jun 2016.