NCT01895686

Brief Summary

The aim of this study is to analyze similarities and evaluate interchangeability of Visante and Cirrus OCT (optical coherent tomography)and to compare agreement between gonioscopy and the two systems for evaluation of anterior segment parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

April 2, 2018

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

December 20, 2012

Last Update Submit

March 29, 2018

Conditions

Keywords

open angle glaucomanarrow anglesangle closure glaucomagonioscopyanterior segment OCT

Outcome Measures

Primary Outcomes (1)

  • anterior angle measurement

    comparison of AS assessment by Cirrus, Visante, gonioscopies

    1 day

Study Arms (3)

Open angle glaucoma

patients diagnosed with open angle glaucoma

Narrow angle

patients diagnosed with narrow angles

Angle Closure Glaucoma

patients diagnosed with angle closure glaucoma

Eligibility Criteria

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

Phakic patients with open, narrow angle and angle closure glaucoma without prior intraocular surgery, including laser iridotomy or topical miotic use, were recruited for this study after Informed Consent was obtained.

You may qualify if:

  • 18 years of age and older with open angle, narrow angle and angle closure

You may not qualify if:

  • All lasers or intraocular surgery (cataract, glaucoma, retina, cornea)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Hu CX, Mantravadi A, Zangalli C, Ali M, Faria BM, Richman J, Wizov SS, Razeghinejad MR, Moster MR, Katz LJ. Comparing Gonioscopy With Visante and Cirrus Optical Coherence Tomography for Anterior Chamber Angle Assessment in Glaucoma Patients. J Glaucoma. 2016 Feb;25(2):177-83. doi: 10.1097/IJG.0000000000000076.

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Leslie J Katz, MD

    Glaucoma Service, Wills Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2012

First Posted

July 10, 2013

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

November 1, 2012

Last Updated

April 2, 2018

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Manuscript has been published in the Journal of Glaucoma.

Locations