NCT00731458

Brief Summary

Ocular Coherence Tomography (OCT) is a non-invasive ophthalmologic test that uses reflected, unheated, non-concentrated visible light in order to scan and provide a 2-dimensional topographic analysis of the retina and optic nerve. It has wide diagnostic utility especially in patients with clinically significant macular edema, glaucoma, and other retinal eye diseases. At the University of Chicago, we have utilized the Stratus brand OCT (Carl Zeiss Inc) for the past 5 years. Recently we have acquired a beta version of the company's new model, the Cirrus HD-OCT (Carl Zeiss Inc.) which features improved resolution, shorter scanning time and a more user-friendly interface. The purpose of this study is to compare findings between the two models in patients with different common and uncommon eye diseases, including diabetic macular edema, glaucoma and age-related macular degeneration. We hypothesis that the Cirrus OCT is able to accurately quantify eye pathology compared to Stratus OCT.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Shorter than P25 for not_applicable

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

May 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

August 6, 2008

Last Update Submit

September 4, 2013

Conditions

Keywords

OCT;Cirrus;Stratus;macular thickness

Interventions

Non-contact retinal thickness analyzer

Also known as: OCT; Cirrus; Stratus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any eye pathology that may cause macular edema.

You may not qualify if:

  • Vitreous media opacities including dense cataracts, vitreous hemorrhage, and corneal opacities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Forooghian F, Cukras C, Meyerle CB, Chew EY, Wong WT. Evaluation of time domain and spectral domain optical coherence tomography in the measurement of diabetic macular edema. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4290-6. doi: 10.1167/iovs.08-2113. Epub 2008 May 30.

    PMID: 18515567BACKGROUND
  • Gupta V, Gupta P, Singh R, Dogra MR, Gupta A. Spectral-domain Cirrus high-definition optical coherence tomography is better than time-domain Stratus optical coherence tomography for evaluation of macular pathologic features in uveitis. Am J Ophthalmol. 2008 Jun;145(6):1018-1022. doi: 10.1016/j.ajo.2008.01.021. Epub 2008 Mar 17.

    PMID: 18343349BACKGROUND

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Seenu Hariprasad, M.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 11, 2008

Study Start

May 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

September 5, 2013

Record last verified: 2013-09