Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Congenital Cataract Clinical Trial

Official title:

Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230799
• Other study ID #: CCPMOH2017-China-3
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2017
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Sun Yat-sen University
• Contact: Jing Li, M.D
• Phone: +86-20-87330341
• Email: Reviewborad_SYsU[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract

Intervention

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.
• traditional cataract surgery
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center,Sun Yat-sen U	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	High intra-ocular pressure	Determined with Tono-Pen tonometer at each follow-up	after lens removal to five years of age.
Secondary	Visual axis opacification	Determined with slit-lamp photography at each follow-up	after lens removal to five years of age.
Secondary	Bi-ocular visual function	Determined with synoptophore	performed when the patient is four years old and five years old.