Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery

Astigmatism Clinical Trial

Official title:

An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02618018
• Other study ID #: AT TORBI 709M toric IOL
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2015
• Last updated: November 25, 2015
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: Mee Kum Kim, MD, PhD
• Phone: 82-10-6277-0798
• Email: kmk9[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and stability of AT TORBI 709M 4-haptic toric IOL in cataract surgery.

Description:

Inclusion criteria

1. senile cataract

2. patients' age of 21 years or older

3. preoperative regular corneal astigmatism between 1.00 D and 6.00 D

Exclusion criteria

1. pregnant, lactating women

2. presence of other ocular diseases which affect stability of lens capsule

Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome :

rotational stability, endothelial cell count, cornea thickness

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• senile cataract

• patients' age of 21 years or older

• preoperative regular corneal astigmatism between 1.00 D and 6.00 D

Exclusion Criteria:

• pregnant, lactating women

• presence of other ocular diseases which affect stability of lens capsule

Study Design

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

Related Conditions & MeSH terms

• Astigmatism
• Iol

Intervention

Procedure:
• AT TORBI 709M
Cataract surgery with AT TORBI 709M 4-haptic toric IOL

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity, refractive results	uncorrected distance visual acuity (UCDVA) and best corrected distance visual acuity (BCDVA) measured using logarithm of the minimum angle of resolution (logMAR) refractive results measured by keratometry	3 months	No
Secondary	Rotational stability	Photographic evaluation of IOL rotation using slit-lamp digital photographs at each postoperative visit, and determine changes in the lens axis between visits.	3 months	Yes
Secondary	Endothelial cell count	measured by specular microscopy	3 months	Yes
Secondary	Cornea thickness	measured by ultrasound pachymetry	3 months	Yes