NCT00926549

Brief Summary

The purpose of this study is to analyze macular retinal thickness and macular volume using the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with various ocular diseases.

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
300

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable healthy

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

May 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 23, 2009

Status Verified

June 1, 2009

Enrollment Period

4 months

First QC Date

May 6, 2009

Last Update Submit

June 19, 2009

Conditions

HealthyMyopiaHypermetropia

Keywords

spectral domain-OCTmacular thicknessmyopiahypermetropianormal

Outcome Measures

Primary Outcomes (1)

  • macular retinal thickness and volume

    3 months

Study Arms (1)

spectral domain-OCT

EXPERIMENTAL

Spectral domain-OCT scanning performed.

Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)

Interventions

Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)DEVICE

macular cube scanning

Also known as: Cirrus™ HD-OCT, Carl Zeiss Meditec AG
spectral domain-OCT

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • normal eyes
  • myopic eyes
  • hypermetropic eyes

You may not qualify if:

  • systemic illness
  • cataract
  • previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University College of Medicine, Gangnam Severance Hospital

Seoul, 135-720, South Korea

RECRUITING

MeSH Terms

Conditions

MyopiaHyperopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Sung Soo Kim, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Soo Kim, MD, PhD

CONTACT

82-2-2019-3443semekim@naver.com

Won Kyung Song, MD

CONTACT

82-2-2228-3591songwk@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2009

First Posted

June 23, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 23, 2009

Record last verified: 2009-06

Locations

KR(1)