Viewing Study NCT02618018


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Study NCT ID: NCT02618018
Status: UNKNOWN
Last Update Posted: 2015-12-01
First Post: 2015-05-20
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
Sponsor: Seoul National University Hospital
Organization:

Study Overview

Official Title: An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
Status: UNKNOWN
Status Verified Date: 2015-11
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: