Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery

Sun Yat-sen University (Other)
Overall Status
Recruiting ID

Study Details

Study Description

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
  • Procedure: minimal invasive lens surgery
  • Procedure: traditional cataract 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 Design

Study Type:
Anticipated Enrollment :
100 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Comparison of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Actual Study Start Date :
Jul 28, 2017
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Best correctied visual acuity [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 [after lens removal to five years of age.]

    Determined with Tono-Pen tonometer at each follow-up

  2. Visual axis opacification [after lens removal to five years of age.]

    Determined with slit-lamp photography at each follow-up

  3. Bi-ocular visual function [performed when the patient is four years old and five years old.]

    Determined with synoptophore

Eligibility Criteria


Ages Eligible for Study:
1 Month to 24 Months
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 Zhongshan Ophthalmic Center,Sun Yat-sen U Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University


  • Principal Investigator: Yizhi Liu, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Haotian Lin, Clinical Professor, Sun Yat-sen University Identifier:
Other Study ID Numbers:
  • CCPMOH2017-China-3
First Posted:
Jul 26, 2017
Last Update Posted:
May 17, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022