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

Primary Purpose

Iol, Astigmatism

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AT TORBI 709M
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iol focused on measuring astigmatism, toric intraocular lens

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intraocular lens

Arm Description

AT TORBI 709M toric intraocular lens

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Endothelial cell count
measured by specular microscopy
Cornea thickness
measured by ultrasound pachymetry

Full Information

First Posted
May 20, 2015
Last Updated
November 25, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02618018
Brief Title
Clinical Evaluation of Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
Official Title
An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iol, Astigmatism
Keywords
astigmatism, toric intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intraocular lens
Arm Type
Experimental
Arm Description
AT TORBI 709M toric intraocular lens
Intervention Type
Procedure
Intervention Name(s)
AT TORBI 709M
Intervention Description
Cataract surgery with AT TORBI 709M 4-haptic toric IOL
Primary Outcome Measure Information:
Title
Visual acuity, refractive results
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rotational stability
Description
Photographic evaluation of IOL rotation using slit-lamp digital photographs at each postoperative visit, and determine changes in the lens axis between visits.
Time Frame
3 months
Title
Endothelial cell count
Description
measured by specular microscopy
Time Frame
3 months
Title
Cornea thickness
Description
measured by ultrasound pachymetry
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mee Kum Kim, MD, PhD
Phone
82-10-6277-0798
Email
kmk9@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Jeong Kim, MD
Phone
82-10-2559-1377
Email
21cnasa@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, MD, PhD
Phone
82-10-6277-0798
Email
kmk9@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Yu Jeong Kim, MD
Phone
82-10-2559-1377
Email
21cnasa@naver.com
First Name & Middle Initial & Last Name & Degree
Mee Kum Kim, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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