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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| traditional cataract surgery | Active Comparator | Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy(ACCC+ I/A + PCCC + Anti-vit) |
|
| minimal invasive lens surgery | Experimental | Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minimal invasive lens surgery | Procedure | We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. |
| Measure | Description | Time Frame |
|---|---|---|
| Best correctied visual acuity | Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age. | recorded at each follow-up to five years of age. |
| Measure | Description | Time Frame |
|---|---|---|
| High intra-ocular pressure | Determined with Tono-Pen tonometer at each follow-up | after lens removal to five years of age. |
| Visual axis opacification | Determined with slit-lamp photography at each follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Li, M.D | Contact | +86-20-87330341 | Reviewborad_SYsU@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu, M.D,Ph.D | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center,Sun Yat-sen U | Recruiting | Guangzhou | Guangdong | 510060 | China |
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|
| traditional cataract surgery | Procedure | ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy |
|
| after lens removal to five years of age. |
| Bi-ocular visual function | Determined with synoptophore | performed when the patient is four years old and five years old. |