NCT00607100

Brief Summary

The purpose of this study is to compare the abilities of high-speed,high-resolution (HR) optical coherence tomography (OCT) and Stratus OCT for detection of retinal nerve fiber layer (RNFL) loss in eyes with band atrophy (BA) of the optic nerve.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

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

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

3 months

First QC Date

February 4, 2008

Last Update Submit

November 11, 2008

Conditions

Band AtrophyChiasmal CompressionNeural Loss

Keywords

High-Resolution Optical Coherence TomographyRetinal Nerve Fiber LayerBand Atrophy

Study Arms (2)

1

Patients with Band atrophy of the optic nerve

2

Normal Controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with band atrophy from chismal compression and controls

You may qualify if:

  • Visual acuity better than 20/30
  • Refractive error less 5 spherical diopter and 3 cylinder diopter
  • Temporal field defect

You may not qualify if:

  • Presence of glaucoma and optic nerve anomalies
  • A normal nasal field

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo - Ophthalmology Department

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • Costa-Cunha LV, Cunha LP, Malta RF, Monteiro ML. Comparison of Fourier-domain and time-domain optical coherence tomography in the detection of band atrophy of the optic nerve. Am J Ophthalmol. 2009 Jan;147(1):56-63.e2. doi: 10.1016/j.ajo.2008.07.020. Epub 2008 Sep 6.

    PMID: 18774548DERIVED

Study Officials

  • Luciana Costa Cunha, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 5, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

November 13, 2008

Record last verified: 2008-11

Locations

BR(1)