Clinical trial NCT03230799: Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
Official title: Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Cataract
Keywords: congenital cataract
minimal invasive surgery
secondary intraocular lens implantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.

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, while in Group II, the participants receive a traditional cataract surgery. A secondary intraocular lens implantation is performed when the patient is two years old for both Group I and Group II. Investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Best correctied visual acuity
timeFrame: recorded at each follow-up to five years of age.
Secondary outcomes:
measure: High intra-ocular pressure
timeFrame: after lens removal to five years of age.
measure: Visual axis opacification
timeFrame: after lens removal to five years of age.
measure: Bi-ocular visual function
timeFrame: performed when the patient is four years old and five years old.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center,Sun Yat-sen U
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: