Congenital CataractNCT02748031
Congenital Cataract Morphological Classifications
A study testing slit-lamp-adapted anterior segmental photography in people with Congenital Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.This study is to investigate the feasibility of congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography in a large cohort… Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- slit-lamp-adapted anterior segmental photography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2016
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with pediatric unilateral/bilateral cataracts
- Children who were younger than 10 years of age
Who cannot join
- Premature birth
- Microphthalmia
- Micro-or Megalocornea
- Keratoconus
- Glaucoma
- Traumatic or complicated cataracts
- Vitreous and retinal diseases
- Any previous surgeries, and contraindication for pupil dilation and sedation
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: Congenital Cataract Morphological Classifications and Monitoring Using Slit-Lamp-Adapted Photography in CCPMOH
Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.This study is to investigate the feasibility of congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography in a large cohort that included uncooperative children.
Read the detailed description
Lens opacities in congenital cataracts have a wide range of presentations.Therefore, it is important to find a method of recording, classifying and monitoring cataract morphologies that is feasible and safe in a large cohort of children with congenital cataracts, including uncooperative children. Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.
In this study, the investigators studied congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography and evaluated its safety and feasibility in pediatric cataract patients registered in the Childhood Cataract Program of the Chinese Ministry of Health.
- Conditions
- Congenital Cataract
- Being tested
- slit-lamp-adapted anterior segmental photography
- Keywords
- Congenital cataracts, Opacity location, Opacity shape, Classification, Clinical applicability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slit-lamp-adapted anterior segmental photographyProcedure or surgery
The eligible patients underwent pupil dilation and slit-lamp-adapted anterior segmental photography to electronically record and monitor the morphology of their cataractous lens.
| Study group | Role | What they receive |
|---|---|---|
| eligible patients group | Experimental | Not described Receives: Procedure: slit-lamp-adapted anterior segmental photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography
All eligible pediatric patients underwent pupil dilation with compound tropicamide eye drops 3 times (1 time every 10 minutes) before the examination or administration of sleep aid medicine. Then, the children underwent slit-lamp-adapted anterior segmental photography (BX900, Haag-Streit AG, Köniz, Switzerland) for each cataractous lens, including one diffuse light photo, one slit-light photo across the cataract and one retro-illumination photo. All photos of the included patients were screened and morphologically classified separately by two pediatric ophthalmologists; a third ophthalmologist was masked and required to make a decision if the first two physicians had different opinions.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,050 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, Erping Long, Sun Yat-sen University
- Investigators
- Hantian Lin, M.D., Ph.D, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D., Ph.D, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityErping Long, M.D., Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748031
- Sponsor's protocol ID
- CCPMOH2016-China4
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.
PubMed 22921386Long E, Lin Z, Chen J, Liu Z, Cao Q, Lin H, Chen W, Liu Y. Monitoring and Morphologic Classification of Pediatric Cataract Using Slit-Lamp-Adapted Photography. Transl Vis Sci Technol. 2017 Nov 2;6(6):2. doi: 10.1167/tvst.6.6.2. eCollection 2017 Nov.
PubMed 29134133
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Cataract Morphological Classifications and Monitoring Using Slit-Lamp-Adapted Photography in CCPMOH
- ClinicalTrials.gov ID
- NCT02748031
- Acronym / sponsor ID
- CCPMOH2016-China4
- Conditions
- Congenital Cataract
- Keywords
- Congenital cataracts, Opacity location, Opacity shape, Classification, Clinical applicability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Apr 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.
Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.This study is to investigate the feasibility of congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography in a large cohort that included uncooperative children.
Detailed description
Lens opacities in congenital cataracts have a wide range of presentations.Therefore, it is important to find a method of recording, classifying and monitoring cataract morphologies that is feasible and safe in a large cohort of children with congenital cataracts, including uncooperative children. Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.
In this study, the investigators studied congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography and evaluated its safety and feasibility in pediatric cataract patients registered in the Childhood Cataract Program of the Chinese Ministry of Health.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eligible patients group | Experimental | Procedure: slit-lamp-adapted anterior segmental photography |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with pediatric unilateral/bilateral cataracts
- Children who were younger than 10 years of age
Key exclusion criteria (8 listed)
- Premature birth
- Microphthalmia
- Micro-or Megalocornea
- Keratoconus
- Glaucoma
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 |
|---|---|---|
| slit-lamp-adapted anterior segmental photographyThe eligible patients underwent pupil dilation and slit-lamp-adapted anterior segmental photography to electronically record and monitor the morphology of their cataractous lens. | Procedure or surgery | eligible patients group |
Primary outcome
Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography
Time frame: baseline
All eligible pediatric patients underwent pupil dilation with compound tropicamide eye drops 3 times (1 time every 10 minutes) before the examination or administration of sleep aid medicine. Then, the children underwent slit-lamp-adapted anterior segmental photography (BX900, Haag-Streit AG, Köniz, Switzerland) for each cataractous lens, including one diffuse light photo, one slit-light photo across the cataract and one retro-illumination photo. All photos of the included patients were screened and morphologically classified separately by two pediatric ophthalmologists; a third ophthalmologist was masked and required to make a decision if the first two physicians had different opinions.
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 22 Apr 2016.
- Background: PubMed 22921386Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.
- Derived from this study: PubMed 29134133Long E, Lin Z, Chen J, Liu Z, Cao Q, Lin H, Chen W, Liu Y. Monitoring and Morphologic Classification of Pediatric Cataract Using Slit-Lamp-Adapted Photography. Transl Vis Sci Technol. 2017 Nov 2;6(6):2. doi: 10.1167/tvst.6.6.2. eCollection 2017 Nov.
- Home page of Zhongshan Ophthalmic CenterLink 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.
Hantian Lin, M.D., Ph.D study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D., Ph.D study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Erping Long, M.D., Ph.D principal investigator
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?
A study testing slit-lamp-adapted anterior segmental photography in people with Congenital 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 8 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 22 Apr 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?
Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography (time frame: baseline). 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 NCT02748031, which also lists 2 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 22 Apr 2016.