Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Cataract
• Intervention / Treatment: Procedure: traditional cataract surgery; Procedure: minimal invasive lens surgery

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center,Sun Yat-sen U

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2017
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: minimal invasive surgery; congenital cataract; secondary intraocular lens implantation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCPMOH2017-China-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No