GlaucomaNCT02708082
Glaucoma HFA / OCT Specificity Study
An observational study of Glaucoma, run by Carl Zeiss Meditec, Inc. at 1 site in United States.
Trial summary
Study consists of five visits over a one to three month time period. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- OCT scanning and HFA perimetry
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Sep 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult males or females 40 to 80 years old with diagnosis of glaucoma, pre-perimetric glaucoma or glaucoma suspect
Who may be able to join
- Adult males or females 40 to 80 years old
- Able and willing to attend the required study visits
- Able and willing to provide consent and follow study instructions in English
- A diagnosis by the Principal Investigator or co-investigator of glaucoma, pre-perimetric glaucoma or glaucoma suspect
- Subjects must have experience in threshold automated perimetry, having performed a previous SITA (Swedish Interactive Thresholding Algorithm) threshold test within one year of enrolling to the study
- Ability to fixate that allows obtaining acceptable visual fields and OCT scans in the study eye
Who cannot join
- • Best-corrected visual acuity less than 20/40 (study eye only) on a Snellen chart or on a Snellen equivalent acuity chart
- Spherical refraction outside -12.00 to +5.00 diopters (D) or cylinder correction outside 3.00 D (study eye only)
- Amblyopia (either eye)
- Narrow irido-corneal angles or a diagnosis of narrow angle glaucoma
- Previous or current eye disease in the study eye, serious eye trauma or intraocular surgery (except cataracts with lens implants), or the presence of ocular findings that could affect the visual field, other than glaucoma
- Cataract surgery in the study eye within six (6) months of first visit
Show all 14Show fewer
- Dx of any optic neuropathy other than glaucoma
- Vitreoretinal traction or epiretinal membrane in the study eye
- Diagnosis or history of any systemic disease / condition / treatment which is likely to affect the visual field outcome in the Study Eye other than glaucoma
- History of diabetes, leukemia, AIDS, uncontrolled systemic high blood pressure, dementia or multiple sclerosis
- Any disease that is likely to progress within the 3 month time period that might have visual field implications
- A life threatening or debilitating disease
- Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE)
- Concomitant use of hydrochloroquine and/or chloroquine
Trial locations and contacts
1 site in 1 country.
Thomas Callan contact
United States1 site
Carl Zeiss Meditec, Inc.
Dublin, California, 94568
T Callan
About this study
Study consists of five visits over a one to three month time period.
Read the detailed description
Each visit consists of optical coherence tomography (OCT) scanning (4 scans ) and two HFA (Humphrey Field Analyzer) visual fields of the study eye only.
- Conditions
- Glaucoma
- Being tested
- OCT scanning and HFA perimetry
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT scanning and HFA perimetryDevice
Imaging of the optic nerve and nerve fiber layer / measurement of visual field
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Early, moderate or advanced glaucoma, glaucoma suspects or pre-perimetric glaucoma will perform OCT scanning and HFA perimetry Receives: Device: OCT scanning and HFA perimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal nerve fiber layer average thickness
Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in microns.
Measured: less than 3 months
Secondary outcomes (3)
Neuroretinal rim thickness
Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in millimeters squared.
Measured: less than 3 months
Mean deviation of visual field
Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in decibels.
Measured: less than 3 months
Pattern standard deviation of the visual field
Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in decibels.
Measured: less than 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Callan, Study director, Carl Zeiss Meditec, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708082
- Sponsor's protocol ID
- COMBO-2015-1
- Status last verified
- Mar 2016
- First submitted
- 24 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma HFA / OCT Specificity Study
- ClinicalTrials.gov ID
- NCT02708082
- Acronym / sponsor ID
- COMBO-2015-1
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 15 Mar 2016 (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.
Study consists of five visits over a one to three month time period.
Detailed description
Each visit consists of optical coherence tomography (OCT) scanning (4 scans ) and two HFA (Humphrey Field Analyzer) visual fields of the study eye only.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Device: OCT scanning and HFA perimetryEarly, moderate or advanced glaucoma, glaucoma suspects or pre-perimetric glaucoma will perform OCT scanning and HFA perimetry |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males or females 40 to 80 years old with diagnosis of glaucoma, pre-perimetric glaucoma or glaucoma suspect
Key inclusion criteria (6 listed)
- Adult males or females 40 to 80 years old
- Able and willing to attend the required study visits
- Able and willing to provide consent and follow study instructions in English
- A diagnosis by the Principal Investigator or co-investigator of glaucoma, pre-perimetric glaucoma or glaucoma suspect
- Subjects must have experience in threshold automated perimetry, having performed a previous SITA (Swedish Interactive Thresholding Algorithm) threshold test within one year of enrolling to the study
Key exclusion criteria (14 listed)
- • Best-corrected visual acuity less than 20/40 (study eye only) on a Snellen chart or on a Snellen equivalent acuity chart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT scanning and HFA perimetryImaging of the optic nerve and nerve fiber layer / measurement of visual field | Device | Glaucoma |
Primary outcome
Retinal nerve fiber layer average thickness
Time frame: less than 3 months
Specificity comparison of results from the five visits will be made. Analysis of variance will be used to determine repeatability and reproducibility - results in microns.
3 secondary outcomes
Neuroretinal rim thickness
Time frame: less than 3 months
Mean deviation of visual field
Time frame: less than 3 months
Pattern standard deviation of the visual field
Time frame: less than 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Thomas Callan contact
Thomas Callan study director
Carl Zeiss Meditec, Inc.
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 Glaucoma, run by Carl Zeiss Meditec, Inc. 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 15 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Callan (9255574834), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal nerve fiber layer average thickness (time frame: less than 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2016.