Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Sun Yat-sen University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Congenital Cataract

Interventions

minimal invasive lens surgeryPROCEDURE

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.

traditional cataract surgeryPROCEDURE

ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy

Eligibility

Sex: ALLMin age: 1 MonthMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Ophthalmic Center,Sun Yat-sen U

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: recorded at each follow-up to five years of age.

Secondary Outcomes

High intra-ocular pressure

Determined with Tono-Pen tonometer at each follow-up

Time frame: after lens removal to five years of age.

Visual axis opacification

Determined with slit-lamp photography at each follow-up

Time frame: after lens removal to five years of age.

Bi-ocular visual function

Determined with synoptophore

Time frame: performed when the patient is four years old and five years old.

Central Contacts

Jing Li, M.D

CONTACT

+86-20-87330341 Reviewborad_SYsU@163.com

Data from ClinicalTrials.gov

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