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

• Sponsor: Kyungpook National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02040129
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Device: Acrysof Toric IOL	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acrysof toric IOL Acrysof Toric intraocular lens in congenital cataract	Device: Acrysof Toric IOL; Lens implantation following cataract surgery

Outcome Measures

Primary Outcome Measures

1. Change from baseline in astigmatism after cataract surgery at 24 months [preop, 3,6,12,24 month postop]

   Measurement of refraction after cataract surgery was performed.

Secondary Outcome Measures

1. Change from baseline in quality of vision after cataract surgery at 24 months. [preop, 3,6,12,24 months postop]

   Measurement of visual acuity after cataract surgery was performed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bo Young Chun, M.D.	Daegu	Kyungsangpookdo	Korea, Republic of	700-721

Sponsors and Collaborators

• Kyungpook National University Hospital

Investigators

• Principal Investigator: Bo Young Chun, M.D, Kyungpook National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bo Young Chun, Department of Ophthalmology, School of medicine, Kyungpook National University, Kyungpook National University Hospital
• ClinicalTrials.gov Identifier: NCT02040129
• Other Study ID Numbers: KNUH2014-01
• First Posted: Jan 20, 2014
• Last Update Posted: Jan 20, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

No Results Posted as of Jan 20, 2014