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NCT01895686 Clinical Trial

Comparison of Gonioscopy With Cirrus and Visante

Open Angle Glaucoma Clinical Trial

— ASOCT  

Official title:
Comparison of Visante and Cirrus Optical Coherent Tomography for Assessment of the Anterior Segment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01895686
Other study ID # 11-080E
Secondary ID
Status Completed
Phase
First received December 20, 2012
Last updated March 29, 2018
Start date November 2011
Est. completion date November 2012

Study information
Verified date November 2016
Source Wills Eye
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

All participants underwent routine ophthalmic examination by their physician. Three independent examiners performed gonioscopy using Spaeth Gonioscopic Grading System. Findings were recorded independently along with risk assessment of angle being closed as: high, medium, and low or no risk. Patient information was not available to doctor during gonioscopy. One eye of each patient was imaged using both Visante and Cirrus OCT. Imaging was performed under scotopic and photopic conditions and obtained from horizontal (3:00 and 9:00 o'clock) and vertical (6:00 and 12:00 o'clock) meridians. The same experienced independent examiner performed all Cirrus measurements. Visante was performed by 3 trained technicians using same protocol.

OCT images were exported and masked to be evaluated for presence of open or closed anterior chamber angle. Masked images were presented with no other patient information available to two examiners with glaucoma training working together to score on basis of iridocorneal angle as, closed (0 degree), high possibility (10 degree), medium risk (20 degree), and low or no risk (> 30 degree).

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date November 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Wills Eye Hospital, Glaucoma Service Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & 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. 2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary anterior angle measurement comparison of AS assessment by Cirrus, Visante, gonioscopies 1 day
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