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

An Investigator-Initiated Trials on the Efficacy and Stability of AT TORBI 709M 4-haptic Toric IOL in Cataract Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02618018

Enrollment

Registered

2015-12-01

Start date

2015-09-30

Completion date

2016-12-31

Last updated

2015-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Iol

Keywords

astigmatism, toric intraocular lens

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

Interventions

PROCEDUREAT TORBI 709M

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Cornea thickness	3 months	measured by ultrasound pachymetry

Countries

South Korea

Contacts

Primary ContactMee Kum Kim, MD, PhD

kmk9@snu.ac.kr82-10-6277-0798

Backup ContactYu Jeong Kim, MD

21cnasa@naver.com82-10-2559-1377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026