Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison 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.
ClinicalTrials.gov Identifier: NCT03230799
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : November 9, 2018
Sponsor:
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: minimal invasive lens surgery Procedure: traditional cataract 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.

Layout table for study information
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 Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Actual Study Start Date : July 28, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

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 correctied visual acuity [ Time Frame: 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 :
  1. High intra-ocular pressure [ Time Frame: after lens removal to five years of age. ]
    Determined with Tono-Pen tonometer at each follow-up

  2. Visual axis opacification [ Time Frame: after lens removal to five years of age. ]
    Determined with slit-lamp photography at each follow-up

  3. Bi-ocular visual function [ Time Frame: performed when the patient is four years old and five years old. ]
    Determined with synoptophore



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03230799


Contacts
Layout table for location contacts
Contact: Jing Li, M.D +86-20-87330341 Reviewborad_SYsU@163.com

Locations
Layout table for location information
China, Guangdong
Zhongshan Ophthalmic Center,Sun Yat-sen U Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Haotian Lin, Phd    +86-20-87330475    gddlht@gmail.com   
Principal Investigator: Haotian Lin, PhD         
Principal Investigator: Yizhi Liu, PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Yizhi Liu, M.D,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

Layout table for additonal information
Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03230799     History of Changes
Other Study ID Numbers: CCPMOH2017-China-3
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases