Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract

Congenital Cataract Clinical Trial

Official title:

Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040129
• Other study ID #: KNUH2014-01
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: January 16, 2014
• Start date: January 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2014
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.

Description:

This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 13 Years

Eligibility

Inclusion Criteria:

• Children less than 14 years

• Congenital cataract at initial visit

• Symmetrical keratometric astigmatism more than 2.0 D

Exclusion Criteria:

• Microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age)

• Corneal pathology

• Keratoconus

• Irregular astigmatism

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Congenital Cataract

Intervention

Device:
• Acrysof Toric IOL
Lens implantation following cataract surgery

Locations

Country	Name	City	State
Korea, Republic of	Bo Young Chun, M.D.	Daegu	Kyungsangpookdo

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in astigmatism after cataract surgery at 24 months	Measurement of refraction after cataract surgery was performed.	preop, 3,6,12,24 month postop	No
Secondary	Change from baseline in quality of vision after cataract surgery at 24 months.	Measurement of visual acuity after cataract surgery was performed.	preop, 3,6,12,24 months postop	No