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

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275764
• Other study ID #: WDD-optic capture
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Wenzhou Medical University
• Contact: Yune Zhao
• Phone: 18258227706
• Email: zyehzeye[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract
• Intraocular Lens Implantation

Intervention

Procedure:
• primary or secondary intraocular lens implantation surgery
primary or secondary intraocular lens implantation surgery

Locations

Country	Name	City	State
China	Eye Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOL position	The horizontal and vertical inclination of IOL	through study completion, an average of 1 year
Primary	BCVA	best corrected visual acuity	through study completion, an average of 1 year