Traumatic CataractNCT07087275
Long-term Visual and Refractive Outcomes After Traumatic Cataract Surgery in Children
An observational study of Traumatic Cataract, run by Jin Yang at 1 site in China.
Trial summary
This prospective multicenter observational study aims to evaluate long-term visual and ocular biometric outcomes in pediatric patients aged 0-16 years who were diagnosed with traumatic cataract and underwent cataract extraction surgery. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Traumatic Cataract
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2010to 1 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will enroll pediatric patients aged 0 to 16 years who were diagnosed with traumatic cataract and underwent cataract surgery at the Eye, Ear, Nose, and Throat Hospital of Fudan University, or the Eye Hospital of Wenzhou Medical University, or the First Affiliated Hospital of Nanjing Medical University. Eligible patients may have experienced either blunt or penetrating ocular trauma. Both unilateral and bilateral cases are included. All participants must be able to complete regular follow-up evaluations for at least 5 years after surgery. The study population reflects a broad spectrum of post-traumatic cataract severity and treatment modalities, representing real-world clinical settings.
Who may be able to join
- Aged 0 to 16 years at the time of trauma-related cataract diagnosis
- Diagnosed with traumatic cataract (due to blunt or penetrating ocular trauma)
- Underwent cataract extraction surgery with or without intraocular lens (IOL) implantation
- Able to attend regular follow-up assessments for at least 5 years postoperatively
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Congenital or developmental cataract
- Pre-existing ocular diseases unrelated to trauma (e.g., congenital glaucoma, retinal dystrophies)
- Severe posterior segment damage precluding reliable visual outcome evaluation (e.g., endophthalmitis, choroidal rupture involving the macula)
- Systemic or neurological disorders that affect vision or compliance with follow-up (e.g., cerebral palsy, intellectual disability)
- Previous intraocular surgery in the affected eye unrelated to the trauma
Trial locations and contacts
1 site in 1 country.
China1 site
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
This prospective multicenter observational study aims to evaluate long-term visual and ocular biometric outcomes in pediatric patients aged 0-16 years who were diagnosed with traumatic cataract and underwent cataract extraction surgery. Medical records of eligible patients with at least 5 to 10 years of postoperative follow-up will be reviewed. Key outcome measures include best-corrected visual acuity (BCVA), axial length, corneal astigmatism, intraocular pressure (IOP), binocular function (fusion and stereopsis), intraocular lens (IOL) position, and postoperative complications. The study seeks to provide insight into long-term visual rehabilitation and prognostic indicators following pediatric traumatic cataract surgery.
- Conditions
- Traumatic Cataract
- Keywords
- Traumatic Cataract, Cataract Surgery, Pediatric 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 |
|---|---|---|
| Traumatic cataract | Traumatic cataract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
UDVA \& BCVA will be assessed using age-appropriate optotypes (e.g., Lea symbols, Snellen chart, or ETDRS chart) and recorded in logMAR units.
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Axial Length Development
Axial Length(mm) measured by IOLMaster700
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Corneal Astigmatism
Measured by Pentacam
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Corneal Astigmatism
Measured by IOLMaster700
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Secondary outcomes (8)
Binocular Function
Binocular fusion and stereopsis will be assessed using standard clinical tools such as Worth 4-dot test and Randot stereoacuity test.
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Intraocular Pressure (IOP)
IOP(mmHg) will be monitored using non-contact or Goldmann applanation tonometry to detect postoperative ocular hypertension or glaucoma.
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Postoperative Complications
Incidence of complications such as secondary glaucoma, visual axis opacification, retinal detachment, or IOL decentration will be recorded.
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Intraocular Lens (IOL) Position
IOL centration and tilt will be evaluated by slit-lamp exam or anterior segment OCT.
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Anterior Chamber Depth (ACD)
Anterior chamber depth (ACD) will be measured using optical biometry and recorded in millimeters (mm) as the distance from the corneal endothelium to the anterior lens surface.
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Lens Thickness (LT)
Lens thickness (LT) will be measured using optical biometry and recorded in millimeters (mm).
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
White-to-White Corneal Diameter (WTW)
WTW corneal diameter will be measured using optical biometry and recorded in millimeters (mm).
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Keratometry
Keratometric values will be measured using optical biometry and recorded in diopters (D).
Measured: From surgery up to 10 years postoperatively, depending on available follow-up duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jun 2010
- Primary completion1 Jun 2020
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Yang
- Sponsor type
- University, hospital or other
- Collaborators
- The Eye Hospital of Wenzhou Medical University, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Sponsor-investigator, Jin Yang, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087275
- Sponsor's protocol ID
- Traumatic Cataract-FDU-2010
- Status last verified
- Dec 2025
- First submitted
- 5 Jul 2025
- Last updated
- 13 Jan 2026
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Visual and Refractive Outcomes After Traumatic Cataract Surgery in Children
- ClinicalTrials.gov ID
- NCT07087275
- Acronym / sponsor ID
- Traumatic Cataract-FDU-2010
- Conditions
- Traumatic Cataract
- Keywords
- Traumatic Cataract, Cataract Surgery, Pediatric Cataract
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jin YangUniversity, hospital or other
- Collaborators
- The Eye Hospital of Wenzhou Medical University, The First Affiliated Hospital with Nanjing Medical University
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 25 Jul 2025 (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.
This prospective multicenter observational study aims to evaluate long-term visual and ocular biometric outcomes in pediatric patients aged 0-16 years who were diagnosed with traumatic cataract and underwent cataract extraction surgery. Medical records of eligible patients with at least 5 to 10 years of postoperative follow-up will be reviewed. Key outcome measures include best-corrected visual acuity (BCVA), axial length, corneal astigmatism, intraocular pressure (IOP), binocular function (fusion and stereopsis), intraocular lens (IOL) position, and postoperative complications. The study seeks to provide insight into long-term visual rehabilitation and prognostic indicators following pediatric traumatic cataract surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic cataract | – | –Traumatic cataract |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will enroll pediatric patients aged 0 to 16 years who were diagnosed with traumatic cataract and underwent cataract surgery at the Eye, Ear, Nose, and Throat Hospital of Fudan University, or the Eye Hospital of Wenzhou Medical University, or the First Affiliated Hospital of Nanjing Medical University. Eligible patients may have experienced either blunt or penetrating ocular trauma. Both unilateral and bilateral cases are included. All participants must be able to complete regular follow-up evaluations for at least 5 years after surgery. The study population reflects a broad spectrum of post-traumatic cataract severity and treatment modalities, representing real-world clinical settings.
Key inclusion criteria (5 listed)
- Aged 0 to 16 years at the time of trauma-related cataract diagnosis
- Diagnosed with traumatic cataract (due to blunt or penetrating ocular trauma)
- Underwent cataract extraction surgery with or without intraocular lens (IOL) implantation
- Able to attend regular follow-up assessments for at least 5 years postoperatively
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (5 listed)
- Congenital or developmental cataract
- Pre-existing ocular diseases unrelated to trauma (e.g., congenital glaucoma, retinal dystrophies)
- Severe posterior segment damage precluding reliable visual outcome evaluation (e.g., endophthalmitis, choroidal rupture involving the macula)
- Systemic or neurological disorders that affect vision or compliance with follow-up (e.g., cerebral palsy, intellectual disability)
- Previous intraocular surgery in the affected eye unrelated to the trauma
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
Visual Acuity
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
UDVA \& BCVA will be assessed using age-appropriate optotypes (e.g., Lea symbols, Snellen chart, or ETDRS chart) and recorded in logMAR units.
Axial Length Development
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Axial Length(mm) measured by IOLMaster700
Corneal Astigmatism
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Measured by Pentacam
Corneal Astigmatism
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Measured by IOLMaster700
8 secondary outcomes
Binocular Function
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Intraocular Pressure (IOP)
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Postoperative Complications
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Intraocular Lens (IOL) Position
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Anterior Chamber Depth (ACD)
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Lens Thickness (LT)
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
White-to-White Corneal Diameter (WTW)
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Keratometry
Time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Traumatic Cataract
RecruitingObservational study
Shanghai Pediatric Cataract Study
Pediatric Cataract, Congenital Cataract
RecruitingObservational study
The Cohort Study of Pediatric Cataract
Pediatric Cataract
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 Traumatic Cataract, run by Jin Yang 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Acuity (time frame: From surgery up to 10 years postoperatively, depending on available follow-up duration). The study lists 4 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 13 Jan 2026.