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Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03908359
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Information provided by (Responsible Party):
Haotian Lin, 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.

Condition or disease Intervention/treatment Phase
Congenital Cataract Procedure: traditional cataract surgery Procedure: minimal invasive lens surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: traditional cataract surgery Procedure: traditional cataract surgery
ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy

Experimental: minimal invasive lens surgery 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.

Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03908359

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Contact: Jing Li, M.D +86-20-87330341

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China, Guangdong
Zhongshan Ophthalmic Center,Sun Yat-sen U Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Haotian Lin, Phd    +86-20-87330475   
Principal Investigator: Haotian Lin, PhD         
Principal Investigator: Yizhi Liu, PhD         
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Yizhi Liu, M.D,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University Identifier: NCT03908359     History of Changes
Other Study ID Numbers: CCPMOH2018-China11
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haotian Lin, Sun Yat-sen University:
Congenital Cataract
minimal invasive surgery
secondary intraocular lens implantation

Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases