NCT02194543

Brief Summary

To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

July 16, 2014

Last Update Submit

July 16, 2014

Conditions

Cataract

Keywords

CataractHD 3DMicroscope

Outcome Measures

Primary Outcomes (1)

  • the best corrected visual acuity

    operation time, total phacoemulsification time, and postoperative visual outcome

    1 month after the operation

Study Arms (2)

HD 3D

The patients received surgeries with HD 3D on their left eyes.

Conventional

The patients received surgeries with conventional method on the other eye.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cataract

You may qualify if:

  • The patients are scheduled to cataract surgery on both eyes.

You may not qualify if:

  • The patients who have other complicating ophthalmic diseases or previous history of ophthalmic surgeries were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 18, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

KR(1)