Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

NCT03230799 | Unknown DMC

• 1 other identifier: CCPMOH2017-China-3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Cataract

Keywords

congenital cataract; minimal invasive surgery; secondary intraocular lens implantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• High intra-ocular pressure

  after lens removal to five years of age.

• Visual axis opacification

  after lens removal to five years of age.

• Bi-ocular visual function

  performed when the patient is four years old and five years old.

Study Arms (2)

traditional cataract surgery

ACTIVE COMPARATOR

Central anterior continuous capsulorhexis (5-6 mm)+ irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy（ACCC+ I/A + PCCC + Anti-vit)

Procedure: traditional cataract surgery

minimal invasive lens surgery

EXPERIMENTAL

Peripheral capsulorhexis opening (1.0-1.5 mm)+irrigation/aspiration

Procedure: minimal invasive lens surgery

Interventions

minimal invasive lens surgery PROCEDURE

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.

minimal invasive lens surgery

traditional cataract surgery PROCEDURE

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

traditional cataract surgery

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center,Sun Yat-sen U

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

• Yizhi Liu, M.D,Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li, M.D

CONTACT

+86-20-87330341; Reviewborad_SYsU@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 26, 2017
• Study Start: July 28, 2017
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)