Status:
UNKNOWN
Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
Lead Sponsor:
Sun Yat-sen University
Conditions:
Congenital Cataract
Eligibility:
All Genders
1-24 years
Phase:
NA
Brief Summary
Previously, we have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at compar...
Detailed Description
Patients with congenital cataract that requires surgical intervention are enrolled. Then the patients are assigned to two groups: Group I: the participants receive a minimal invasive lens surgery, whi...
Eligibility Criteria
Inclusion
- Age between 1 month and 24 months
- Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
- Informed consent signed by a parent or legal guardian
Exclusion
- confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract
- Intraocular pressure \>21 mmHg
- Preterm birth (\<28 weeks)
- Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
- History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
- History of ocular trauma
- Microcornea
- Persistent hyperplastic primary vitreous
- Rubella
- Lowe syndrome
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03230799
Start Date
July 28 2017
End Date
December 1 2022
Last Update
May 17 2022
Active Locations (1)
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1
Zhongshan Ophthalmic Center,Sun Yat-sen U
Guangzhou, Guangdong, China, 510060