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

Not Applicable

• Conditions: Iol; Astigmatism
• Interventions: Procedure: AT TORBI 709M

• Registration Number: NCT02618018
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2015-05-20
• Study Start: 2015-09
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-25
• Last Update Submitted: 2015-11-25
• Study First Posted: 2015-12-01
• Last Update Posted: 2015-12-01
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• senile cataract
• patients' age of 21 years or older
• preoperative regular corneal astigmatism between 1.00 D and 6.00 D

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Exclusion Criteria

• pregnant, lactating women
• presence of other ocular diseases which affect stability of lens capsule

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intraocular lens	AT TORBI 709M	AT TORBI 709M toric intraocular lens

Primary Outcome Measures

Name	Time	Method
Visual acuity, refractive results	3 months	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

Secondary Outcome Measures

Name	Time	Method
Cornea thickness	3 months	measured by ultrasound pachymetry
Rotational stability	3 months	Photographic evaluation of IOL rotation using slit-lamp digital photographs at each postoperative visit, and determine changes in the lens axis between visits.
Endothelial cell count	3 months	measured by specular microscopy

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of