Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract

March 10, 2022 updated by: Yune Zhao, Wenzhou Medical University
Approximately 30 eyes with congenital cataract who underwent primary or secondary intraocular lens implantation surgery at Zhejiang Eye Hospital from March 2018 to December 2020 were enrolled. According to the implantation method of IOL, patients were devided into the optic capture group and the endocapsular group. And through the clinical parameters of postoperative best corrected visual acuity (BCVA), intraocular pressure (IOP), IOL position and whether appear visual axis opacity to compare the outcome of the 2 IOL implantation methods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • Eye Hospital of Wenzhou Medical College
        • Contact:
          • Dandan Wang, MD
          • Phone Number: 18258227706

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 year to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with congenital cataracts who underwent primary or secondary intraocular lens implantation surgery at the Eye Hospital Affiliated to Wenzhou Medical University.

Description

Inclusion Criteria:

  • Children aged 1 to 10 years diagnosed with congenital cataract
  • underwent I / II IOL implantation in our hospital
  • corneal diameter more than 9mm
  • Good compliance

Exclusion Criteria:

  • Patients with other ocular or systemic diseases
  • patients whose IOL cannot be implanted in or after the capsule due to ocular conditions
  • Children with a history of other ocular surgery
  • Low compliance

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
optic capture group
IOL optic was captured through the posterior continuous curvilinear capsulorhexis
Procedure: primary or secondary intraocular lens implantation surgery
primary or secondary intraocular lens implantation surgery
endocapsular group
IOL was placed in the bag
Procedure: primary or secondary intraocular lens implantation surgery
primary or secondary intraocular lens implantation surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOL position
Time Frame: through study completion, an average of 1 year
The horizontal and vertical inclination of IOL
through study completion, an average of 1 year
BCVA
Time Frame: through study completion, an average of 1 year
best corrected visual acuity
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Wenzhou Medical University

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)

November 1, 2021

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

February 19, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (ACTUAL)

March 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WDD-optic capture

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.

Subscribe