Clinical Evaluation of Efficacy and Stability of AT TORBI... | NCT02618018

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

NCT02618018

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 1, 2015Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Iol
Astigmatism

Interventions

AT TORBI 709M

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

May 20, 2015

First Submission Date that Met QC Criteria

Nov 25, 2015

First Posted Date

Dec 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2015

Last Update Posted Date

Dec 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Primary outcome : efficacy index (visual acuity, refractive results Secondary outcome : rotational stability, endothelial cell count, cornea thickness

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intraocular lens	Experimental	AT TORBI 709M toric intraocular lens	Procedure: AT TORBI 709M

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AT TORBI 709M	Procedure	Cataract surgery with AT TORBI 709M 4-haptic toric IOL	intraocular lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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
Endothelial cell count

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mee Kum Kim, MD, PhD	Contact	82-10-6277-0798		kmk9@snu.ac.kr
Yu Jeong Kim, MD	Contact	82-10-2559-1377		21cnasa@naver.com

Overall Officials

Name	Affiliation	Role
Mee Kum Kim, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul	Seoul	110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D064090	Intraocular Lymphoma
D001251	Astigmatism

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D005134	Eye Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided