Comparing two surgical techniques for congenital cataracts in children
Comparison of Posterior Continuous Curvilinear Capsulorhexis With or Without Anterior Vitrectomy in Congenital Cataract Surgery
This study is testing two different surgical methods for treating congenital cataracts in children to see which one leads to fewer complications and better vision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05136209 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of posterior continuous curvilinear capsulorhexis (PCCC) with and without anterior vitrectomy (A-Vit) in children undergoing surgery for congenital cataracts. The study involves a randomized controlled design where each child receives surgery on both eyes, with one eye undergoing the PCCC+A-Vit procedure and the other undergoing PCCC alone. The primary focus is to assess postoperative complications such as visual axis opacity and intraocular pressure. By comparing these two approaches, the study seeks to determine the best surgical method to minimize risks and improve outcomes for young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old with bilateral congenital cataracts and no other ocular abnormalities.
Not a fit: Patients with a history of ocular trauma, intraocular surgery, or elevated intraocular pressure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that reduce postoperative complications in children with congenital cataracts.
How similar studies have performed: Previous studies have explored various surgical techniques for cataracts, but this specific comparison of PCCC with and without A-Vit in children is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with bilateral congenital cataracts without other ocular abnormalities * Gestational age at birth \>37 weeks * No more than 18 years old * Pupils could dilate normally pre-operation * Have signed a consent form * Can be followed Exclusion Criteria: * Intraocular pressure \>21 mmHg * History of ocular trauma and intraocular surgery
Where this trial is running
Guangzhou, Guangdong
- Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Weirong Chen, MD — Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study coordinator: Tingfeng Qin
- Email: qintf3@mail2.sysu.edu.cn
- Phone: 13724104066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.