Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|Active Comparator: traditional cataract surgery
Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit)
Procedure: traditional cataract surgery
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
|Experimental: minimal invasive lens surgery
Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration
Procedure: minimal invasive lens surgery
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.
Primary Outcome Measures
- Best correctied visual acuity [recorded at each follow-up to five years of age.]
Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age.
Secondary Outcome Measures
- High intra-ocular pressure [after lens removal to five years of age.]
Determined with Tono-Pen tonometer at each follow-up
- Visual axis opacification [after lens removal to five years of age.]
Determined with slit-lamp photography at each follow-up
- Bi-ocular visual function [performed when the patient is four years old and five years old.]
Determined with synoptophore
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
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
Persistent hyperplastic primary vitreous
Contacts and Locations
|1||Zhongshan Ophthalmic Center,Sun Yat-sen U||Guangzhou||Guangdong||China||510060|
Sponsors and Collaborators
- Sun Yat-sen University
- Principal Investigator: Yizhi Liu, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)None provided.