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

Sponsor
Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05275764
Collaborator
(none)
30
1
14
2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: primary or secondary intraocular lens implantation surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of the Efficacy of Intraocular Lens Optic Capture and In-the-bag Implantation Over 1 Year in Children With Congenital Cataract
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. IOL position [through study completion, an average of 1 year]

    The horizontal and vertical inclination of IOL

  2. BCVA [through study completion, an average of 1 year]

    best corrected visual acuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Hospital of Wenzhou Medical College Wenzhou Zhejiang China 325027

Sponsors and Collaborators

  • Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05275764
Other Study ID Numbers:
  • WDD-optic capture
First Posted:
Mar 11, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022