NCT02362334

Brief Summary

This study evaluates the various ocular parameters which are necessary for ocular biometry and the calculated IOL powers using both dual Schiempflug analyzer and optical low-coherence refelctometry.

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
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
Last Updated

February 18, 2015

Status Verified

October 1, 2014

Enrollment Period

4 months

First QC Date

February 9, 2015

Last Update Submit

February 15, 2015

Conditions

Cataract

Keywords

dual Sheimpflug analyzerintraocular lens poweroptical low-coherence reflectometry

Outcome Measures

Primary Outcomes (2)

  • Ocular parameters

    Parameters measured using two devices were compared at a single point

    Single point

  • Calculated IOL powers

    Calculated IOL powers using two devices were compared at a single point

    Single point

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

140 eyes of patients who scheduled for cataract surgery

You may qualify if:

  • axial length between 21.0 and 27.0 mm
  • older than 20 years old

You may not qualify if:

  • other ophthalmic diseases such as severe dry eye, glaucoma, and age-related macular degeneration
  • previous ophthalmic surgery including cataract surgery, and refractive surgery
  • very dense media which cannot be measured by the optical biometries
  • severe zonulysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, 200-798, South Korea

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Kyung Eun Han, MD

    Clinical associate professor

    STUDY CHAIR

Central Study Contacts

Kyung Eun Han, MD

CONTACT

82-10-3084-6646hkeoph@gmail.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 12, 2015

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 18, 2015

Record last verified: 2014-10

Locations

KR(1)