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NCT Number: NCT07070037

Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery

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.

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Key information

Conditions

Congenital Cataract Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pediatric Cataract Sensation Disorders Signs and Symptoms Vision Disorders

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Xuanqiao Lin

CONTACT

[email protected]

15088920668

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. IOP

    Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

    intraocular pressure

  2. 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.

    Flat (K1) and steep (K2) corneal curvature values will be measured using Pentacam and recorded in diopters (D).

  3. Stereopsis

    Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

    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.

  4. 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.

    WTW (mm)

  5. 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.

    ACD(mm)

  6. Complications

    Time frame: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and annually from 1 to 5 years postoperatively.

    Any postoperative complications following congenital cataract surgery, including glaucoma, anterior capsular opacification (ACO), etc.

  7. 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 pachymetry will be measured with Pentacam at the central point and reported in microns (µm).

  8. 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.

    Corneal astigmatism will be calculated from the difference between steep and flat meridians (K2-K1) using Pentacam data, and reported in diopters.

  9. 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.

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Cai

CONTACT

[email protected]

Xuanqiao Lin

CONTACT

[email protected]

+8615088920668

Sponsors and collaborators

Lead sponsor

Jin Yang

Other

Registry information

Official study title

Five-Year Visual Function and Refractive Outcomes After Congenital Cataract Surgery: A Multicenter Observational Cohort Study

Important dates

Study start
2014
Primary completion
2030
Study completion
2035
First posted
Jul 17, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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