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

NCT ID: NCT02618018

Last Updated: 2015-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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

Conditions

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Iol Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intraocular lens

AT TORBI 709M toric intraocular lens

Group Type EXPERIMENTAL

AT TORBI 709M

Intervention Type PROCEDURE

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

Interventions

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AT TORBI 709M

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mee Kum Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Mee Kum Kim, MD, PhD

Role: CONTACT

82-10-6277-0798

Yu Jeong Kim, MD

Role: CONTACT

82-10-2559-1377

Facility Contacts

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Mee Kum Kim, MD, PhD

Role: primary

82-10-6277-0798

Yu Jeong Kim, MD

Role: backup

82-10-2559-1377

Other Identifiers

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AT TORBI 709M toric IOL

Identifier Type: -

Identifier Source: org_study_id