ASOCT: Comparison of Gonioscopy With Cirrus and Visante

Sponsor

Wills Eye (Other)

Overall Status

Completed

CT.gov ID

NCT01895686

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Narrow Angles Angle Closure Glaucoma

Detailed 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).

Study Design

Study Type:

Observational

Actual Enrollment :

54 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

anterior angle measurement [1 day]
comparison of AS assessment by Cirrus, Visante, gonioscopies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wills Eye Hospital, Glaucoma Service	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Wills Eye

Investigators

Principal Investigator: Leslie J Katz, MD, Glaucoma Service, Wills Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

L. Jay Katz MD, Principal Investigator, Wills Eye

ClinicalTrials.gov Identifier:

NCT01895686

Other Study ID Numbers:

11-080E

First Posted:

Jul 10, 2013

Last Update Posted:

Apr 2, 2018

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by L. Jay Katz MD, Principal Investigator, Wills Eye

open angle glaucoma

narrow angles

angle closure glaucoma

gonioscopy

anterior segment OCT

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Glaucoma, Angle-Closure

Study Results

No Results Posted as of Apr 2, 2018