NCT02618018

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 1, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

May 20, 2015

Last Update Submit

November 25, 2015

Conditions

IolAstigmatism

Keywords

astigmatismtoric intraocular lens

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Rotational stability

    3 months

  • Endothelial cell count

    3 months

  • Cornea thickness

    3 months

Study Arms (1)

intraocular lens

EXPERIMENTAL

AT TORBI 709M toric intraocular lens

Procedure: AT TORBI 709M

Interventions

AT TORBI 709MPROCEDURE

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

intraocular lens

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • senile cataract
  • patients' age of 21 years or older
  • preoperative regular corneal astigmatism between 1.00 D and 6.00 D

You may not qualify if:

  • pregnant, lactating women
  • presence of other ocular diseases which affect stability of lens capsule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Intraocular LymphomaAstigmatism

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsEye NeoplasmsNeoplasms by SiteLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesRefractive ErrorsEye Diseases

Study Officials

  • Mee Kum Kim, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mee Kum Kim, MD, PhD

CONTACT

82-10-6277-0798kmk9@snu.ac.kr

Yu Jeong Kim, MD

CONTACT

82-10-2559-137721cnasa@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

December 1, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 1, 2015

Record last verified: 2015-11

Locations

KR(1)