Open Angle GlaucomaASOCTNCT01895686
Comparison of Gonioscopy With Cirrus and Visante
An observational study of Open Angle Glaucoma and Narrow Angles, run by Wills Eye at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Narrow Angles, Angle Closure Glaucoma
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years of age and older with open angle, narrow angle and angle closure
Who cannot join
- All lasers or intraocular surgery (cataract, glaucoma, retina, cornea)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Hospital, Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
Official title: Comparison of Visante and Cirrus Optical Coherent Tomography for Assessment of the Anterior Segment
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.
Read the 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).
- Conditions
- Open Angle Glaucoma, Narrow Angles, Angle Closure Glaucoma
- Keywords
- open angle glaucoma, narrow angles, angle closure glaucoma, gonioscopy, anterior segment OCT
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior angle measurement
comparison of AS assessment by Cirrus, Visante, gonioscopies
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L. Jay Katz MD, Wills Eye
- Investigators
- Leslie J Katz, MD, Principal investigator, Glaucoma Service, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895686
- Sponsor's protocol ID
- 11-080E
- Acronym
- ASOCT
- Status last verified
- Nov 2016
- First submitted
- 20 Dec 2012
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Manuscript has been published in the Journal of Glaucoma.
Publications
Hu CX, Zangalli C, Mantravadi A, Ali M, Faria BM, Richman J, Wizov SS, Razeghinejad MR, Moster MR, Katz LJ: Comparison of gonioscopy with Visante and Cirrus optical coherence tomography (OCT) for anterior chamber angle assessment in glaucoma patients. Investigative Ophthalmology Program Summary 5/8/2013 4822/D0261.
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.
PubMed 24844543
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visante and Cirrus Optical Coherent Tomography for Assessment of the Anterior Segment
- ClinicalTrials.gov ID
- NCT01895686
- Acronym / sponsor ID
- ASOCT / 11-080E
- Conditions
- Open Angle Glaucoma, Narrow Angles, Angle Closure Glaucoma
- Keywords
- open angle glaucoma, narrow angles, angle closure glaucoma, gonioscopy, anterior segment OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 18 years of age and older with open angle, narrow angle and angle closure
Key exclusion criteria (1 listed)
- All lasers or intraocular surgery (cataract, glaucoma, retina, cornea)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
anterior angle measurement
Time frame: 1 day
comparison of AS assessment by Cirrus, Visante, gonioscopies
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Results publicationHu CX, Zangalli C, Mantravadi A, Ali M, Faria BM, Richman J, Wizov SS, Razeghinejad MR, Moster MR, Katz LJ: Comparison of gonioscopy with Visante and Cirrus optical coherence tomography (OCT) for anterior chamber angle assessment in glaucoma patients. Investigative Ophthalmology Program Summary 5/8/2013 4822/D0261.
- Results publication: PubMed 24844543Hu 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.
- Individual participant dataSharing planned: No. Manuscript has been published in the Journal of Glaucoma.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie J Katz, MD principal investigator
Glaucoma Service, Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma and Narrow Angles, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anterior angle measurement (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01895686, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.