Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Not Applicable

• Conditions: Congenital Cataract
• Interventions: Procedure: minimal invasive lens surgery; Procedure: traditional cataract surgery

• Registration Number: NCT03230799
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-26
• Study Start: 2017-07-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-17
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
minimal invasive lens surgery	minimal invasive lens surgery	Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration
traditional cataract surgery	traditional cataract surgery	Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center,Sun Yat-sen U; 🇨🇳 Guangzhou, Guangdong, China