Comparison of Gonioscopy With Cirrus and Visante

NCT ID: NCT01895686

Last Updated: 2018-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Open Angle Glaucoma Narrow Angles Angle Closure Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Open angle glaucoma

patients diagnosed with open angle glaucoma

No interventions assigned to this group

Narrow angle

patients diagnosed with narrow angles

No interventions assigned to this group

Angle Closure Glaucoma

patients diagnosed with angle closure glaucoma

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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L. Jay Katz MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leslie J Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma Service, Wills Eye Hospital

Locations

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Wills Eye Hospital, Glaucoma Service

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24844543 (View on PubMed)

Other Identifiers

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11-080E

Identifier Type: -

Identifier Source: org_study_id

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