Congenital CataractNCT07070037
Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery
An observational study of Congenital Cataract and Pediatric Cataract, run by Jin Yang at 1 site in China.
Trial summary
This prospective multicenter observational study aims to evaluate the 5-year visual function and refractive outcomes in children undergoing surgery for congenital cataract. Key outcomes include best-corrected visual acuity, stereopsis, refractive error, and axial length growth. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Cataract, Pediatric Cataract
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2035
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will enroll pediatric patients diagnosed with congenital cataract who underwent cataract extraction with or without intraocular lens (IOL) implantation. Participants must be able to complete regular postoperative follow-up assessments from the time of surgery up to 5 years. Both unilateral and bilateral cases are eligible. The study population is recruited from multiple tertiary eye centers in China.
Who may be able to join
- Diagnosis of congenital cataract
- Underwent cataract extraction before 1 year of age
- Available for regular follow-up for at least 5 years postoperatively
- Written informed consent from legal guardian
Who cannot join
- Acquired cataract or traumatic origin
- Associated ocular malformations (e.g., microphthalmia, coloboma)
- Systemic syndromes affecting vision (e.g., Down syndrome)
- History of secondary surgery affecting visual outcome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lei Cai contact
China1 site, 1 recruiting
- Recruiting
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Xuanqiao Lin, 15088920668, 1532483480@qq.com
About this study
Official title: Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery: A Multicenter Observational Cohort Study
This prospective multicenter observational study aims to evaluate the 5-year visual function and refractive outcomes in children undergoing surgery for congenital cataract. Key outcomes include best-corrected visual acuity, stereopsis, refractive error, and axial length growth. The study will help identify long-term trends and prognostic indicators after early cataract intervention in pediatric patients.
- Conditions
- Congenital Cataract, Pediatric Cataract
- Keywords
- Congenital Cataract, Pediatric Cataract Surgery, Visual Function, Stereopsis, Amblyopia, Long-term Outcomes
- Medical subject headings
- Amblyopia
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 |
|---|---|---|
| congenital cataract | congenital cataract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
UDVA and BCVA will be assessed using age-appropriate optotypes (e.g., Snellen chart, ETDRS chart, or Lea symbols) and recorded in logMAR units at the last available follow-up, with a minimum duration of 5 years postoperatively.
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
axial length
AL
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Refractive Error
Refractive Error
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Secondary outcomes (9)
IOP
intraocular pressure
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Corneal Curvature (K1 and K2) by Pentacam
Flat (K1) and steep (K2) corneal curvature values will be measured using Pentacam and recorded in diopters (D).
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Stereopsis
Stereopsis will be assessed using age-appropriate tools (e.g., Randot Preschool or Titmus Fly Test) and reported in seconds of arc. Loss of stereopsis is defined as >3000 arcsec.
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
white to white
WTW (mm)
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
anterior chamber depth
ACD(mm)
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Complications
Any postoperative complications following congenital cataract surgery, including glaucoma, anterior capsular opacification (ACO), etc.
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Central Corneal Thickness (CCT)
Corneal pachymetry will be measured with Pentacam at the central point and reported in microns (µm).
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Corneal Astigmatism Magnitude
Corneal astigmatism will be calculated from the difference between steep and flat meridians (K2-K1) using Pentacam data, and reported in diopters.
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Binocular Fusion Assessment
Binocular fusion will be evaluated using the Worth 4-Dot test under near and distance conditions. Results will be categorized as "fusion", "suppression", or "alternation".
Measured: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jan 2014
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Jin Yang, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070037
- Sponsor's protocol ID
- Congenital Cataract-2025-001
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery: A Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07070037
- Acronym / sponsor ID
- Congenital Cataract-2025-001
- Conditions
- Congenital Cataract, Pediatric Cataract
- Keywords
- Congenital Cataract, Pediatric Cataract Surgery, Visual Function, Stereopsis, Amblyopia, Long-term Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jin YangUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 17 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 the 5-year visual function and refractive outcomes in children undergoing surgery for congenital cataract. Key outcomes include best-corrected visual acuity, stereopsis, refractive error, and axial length growth. The study will help identify long-term trends and prognostic indicators after early cataract intervention in pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| congenital cataract | – | –congenital cataract |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will enroll pediatric patients diagnosed with congenital cataract who underwent cataract extraction with or without intraocular lens (IOL) implantation. Participants must be able to complete regular postoperative follow-up assessments from the time of surgery up to 5 years. Both unilateral and bilateral cases are eligible. The study population is recruited from multiple tertiary eye centers in China.
Key inclusion criteria (4 listed)
- Diagnosis of congenital cataract
- Underwent cataract extraction before 1 year of age
- Available for regular follow-up for at least 5 years postoperatively
- Written informed consent from legal guardian
Key exclusion criteria (4 listed)
- Acquired cataract or traumatic origin
- Associated ocular malformations (e.g., microphthalmia, coloboma)
- Systemic syndromes affecting vision (e.g., Down syndrome)
- History of secondary surgery affecting visual outcome
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: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
UDVA and BCVA will be assessed using age-appropriate optotypes (e.g., Snellen chart, ETDRS chart, or Lea symbols) and recorded in logMAR units at the last available follow-up, with a minimum duration of 5 years postoperatively.
axial length
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
AL
Refractive Error
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Refractive Error
9 secondary outcomes
IOP
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Corneal Curvature (K1 and K2) by Pentacam
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Stereopsis
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
white to white
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
anterior chamber depth
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Complications
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Central Corneal Thickness (CCT)
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Corneal Astigmatism Magnitude
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
Binocular Fusion Assessment
Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.
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 20 Aug 2025.
- 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.
Lei Cai contact
Jin Yang study chair
Fudan 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 Congenital Cataract and Pediatric 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Aug 2025. 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?
Contact Xuanqiao Lin (+8615088920668, 1532483480@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.). 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?
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 20 Aug 2025.