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

April 20, 2022 updated by: Haotian Lin, Sun Yat-sen University

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

Previously, the investigators 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

Detailed Description

Patients with congenital cataract that requires surgical intervention are enrolled.

Then the participants 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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: traditional cataract surgery
Central anterior continuous capsulorhexis opening (5-6 mm)+ lens irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit)
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)+lens irrigation/aspiration
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 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.
up to five years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

November 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

April 6, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (ACTUAL)

April 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2018-China11

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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