GlaucomaNCT01076114
Comparison of Critical Flicker Fusion Versus Automated Visual Fields in the Detection of Early Glaucoma
An observational study of Glaucoma, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if critical flicker fusion is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be selected from routine clinic patients seen at the Eye Center at Nassau University Medical Center, in East Meadow, NY.
Who may be able to join
- Glaucoma Suspects:
- Abnormal optic disc appearance with increased cup to disc ratio, or
- Increased intraocular pressure >21 in either eye
- Control Subjects:
- Normal appearing optic discs
- Normal intraocular pressure (<21)
Who cannot join
- Other ocular pathology
- History of seizures or epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Nassau University Medical Center
East Meadow, New York, 11554
About this study
Official title: Comparison of Critical Flicker Fusion vs. Automated Visual Fields in the Detection of Early Glaucoma
The purpose of this study is to evaluate if critical flicker fusion is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease.
Read the detailed description
Our hypothesis is that critical flicker fusion (CFF) is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease. We aim to evaluate the structure of the optic nerve and compare it to results of visual fields and CFF. The CFF will also be correlated with intraocular pressure (IOP) measurements to observe if it may be more closely related than visual fields. This may become an additional tool to detect glaucoma in those with unreliable visual fields or who are unable to perform a visual field from physical or mental limitations.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
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 |
|---|---|---|
| Control | Patients with no evidence of glaucoma or as a suspect with normal intraocular pressure, normal cup to disc ratio with no other ocular pathology and a normal ophthalmic exam. | |
| Glaucoma Suspect | Patients with abnormal cup to disc ratio or increased intraocular pressure (>21mm/Hg) with an otherwise normal ophthalmic exam. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of mean deviation of glaucoma suspects from controls between critical flicker fusion and automated visual fields.
Measured: 1 visit (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Nassau University Medical Center
- Investigators
- Colin Scott, MD, Principal investigator, Nassau University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076114
- Sponsor's protocol ID
- 09-320
- Status last verified
- Mar 2011
- First submitted
- 24 Feb 2010
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen PC, Woung LC, Yang CF. Modulation transfer function and critical flicker frequency in high-myopia patients. J Formos Med Assoc. 2000 Jan;99(1):45-8.
PubMed 10743346Van Toi V, Grounauer PA, Burckhardt CW. Artificially increasing intraocular pressure causes flicker sensitivity losses. Invest Ophthalmol Vis Sci. 1990 Aug;31(8):1567-74.
PubMed 2387687Riddell LA. THE USE OF THE FLICKER PHENOMENON IN THE INVESTIGATION OF THE FIELD OF VISION. Br J Ophthalmol. 1936 Jul;20(7):385-410. doi: 10.1136/bjo.20.7.385. No abstract available.
PubMed 18169373Chang TT, Ciuffreda KJ, Kapoor N. Critical flicker frequency and related symptoms in mild traumatic brain injury. Brain Inj. 2007 Sep;21(10):1055-62. doi: 10.1080/02699050701591437.
PubMed 17891568Sharma P, Sharma BC, Tyagi P, Kumar M, Sarin SK. Neuropsychological impairment in severe acute viral hepatitis is due to minimal hepatic encephalopathy. Liver Int. 2009 Feb;29(2):260-4. doi: 10.1111/j.1478-3231.2008.01856.x. Epub 2008 Aug 14.
PubMed 18710429Patterson VH, Foster DH, Heron J, Mason RJ. Multiple sclerosis. Luminance threshold and measurements of temporal characteristics of vision. Arch Neurol. 1981 Nov;38(11):687-9. doi: 10.1001/archneur.1981.00510110047005.
PubMed 7305696Tyler CW. Specific deficits of flicker sensitivity in glaucoma and ocular hypertension. Invest Ophthalmol Vis Sci. 1981 Feb;20(2):204-12.
PubMed 7461923Yoshiyama KK, Johnson CA. Which method of flicker perimetry is most effective for detection of glaucomatous visual field loss? Invest Ophthalmol Vis Sci. 1997 Oct;38(11):2270-7.
PubMed 9344350Matsumoto C, Takada S, Okuyama S, Arimura E, Hashimoto S, Shimomura Y. Automated flicker perimetry in glaucoma using Octopus 311: a comparative study with the Humphrey Matrix. Acta Ophthalmol Scand. 2006 Apr;84(2):210-5. doi: 10.1111/j.1600-0420.2005.00588.x.
PubMed 16637839Tielsch JM, Sommer A, Katz J, Royall RM, Quigley HA, Javitt J. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA. 1991 Jul 17;266(3):369-74.
PubMed 2056646Javitt JC, McBean AM, Nicholson GA, Babish JD, Warren JL, Krakauer H. Undertreatment of glaucoma among black Americans. N Engl J Med. 1991 Nov 14;325(20):1418-22. doi: 10.1056/NEJM199111143252005.
PubMed 1922253
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Critical Flicker Fusion vs. Automated Visual Fields in the Detection of Early Glaucoma
- ClinicalTrials.gov ID
- NCT01076114
- Acronym / sponsor ID
- 09-320
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Nassau University Medical Center
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Feb 2010 (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 purpose of this study is to evaluate if critical flicker fusion is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease.
Detailed description
Our hypothesis is that critical flicker fusion (CFF) is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease. We aim to evaluate the structure of the optic nerve and compare it to results of visual fields and CFF. The CFF will also be correlated with intraocular pressure (IOP) measurements to observe if it may be more closely related than visual fields. This may become an additional tool to detect glaucoma in those with unreliable visual fields or who are unable to perform a visual field from physical or mental limitations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients with no evidence of glaucoma or as a suspect with normal intraocular pressure, normal cup to disc ratio with no other ocular pathology and a normal ophthalmic exam. |
| Glaucoma Suspect | – | –Patients with abnormal cup to disc ratio or increased intraocular pressure (>21mm/Hg) with an otherwise normal ophthalmic exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from routine clinic patients seen at the Eye Center at Nassau University Medical Center, in East Meadow, NY.
Key inclusion criteria (6 listed)
- Glaucoma Suspects:
- Abnormal optic disc appearance with increased cup to disc ratio, or
- Increased intraocular pressure >21 in either eye
- Control Subjects:
- Normal appearing optic discs
Key exclusion criteria (2 listed)
- Other ocular pathology
- History of seizures or epilepsy
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
Difference of mean deviation of glaucoma suspects from controls between critical flicker fusion and automated visual fields.
Time frame: 1 visit (1 day)
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 15 Mar 2011.
- Background: PubMed 10743346Chen PC, Woung LC, Yang CF. Modulation transfer function and critical flicker frequency in high-myopia patients. J Formos Med Assoc. 2000 Jan;99(1):45-8.
- Background: PubMed 2387687Van Toi V, Grounauer PA, Burckhardt CW. Artificially increasing intraocular pressure causes flicker sensitivity losses. Invest Ophthalmol Vis Sci. 1990 Aug;31(8):1567-74.
- Background: PubMed 18169373Riddell LA. THE USE OF THE FLICKER PHENOMENON IN THE INVESTIGATION OF THE FIELD OF VISION. Br J Ophthalmol. 1936 Jul;20(7):385-410. doi: 10.1136/bjo.20.7.385. No abstract available.
- Background: PubMed 17891568Chang TT, Ciuffreda KJ, Kapoor N. Critical flicker frequency and related symptoms in mild traumatic brain injury. Brain Inj. 2007 Sep;21(10):1055-62. doi: 10.1080/02699050701591437.
- Background: PubMed 18710429Sharma P, Sharma BC, Tyagi P, Kumar M, Sarin SK. Neuropsychological impairment in severe acute viral hepatitis is due to minimal hepatic encephalopathy. Liver Int. 2009 Feb;29(2):260-4. doi: 10.1111/j.1478-3231.2008.01856.x. Epub 2008 Aug 14.
- Background: PubMed 7305696Patterson VH, Foster DH, Heron J, Mason RJ. Multiple sclerosis. Luminance threshold and measurements of temporal characteristics of vision. Arch Neurol. 1981 Nov;38(11):687-9. doi: 10.1001/archneur.1981.00510110047005.
- Background: PubMed 7461923Tyler CW. Specific deficits of flicker sensitivity in glaucoma and ocular hypertension. Invest Ophthalmol Vis Sci. 1981 Feb;20(2):204-12.
- Background: PubMed 9344350Yoshiyama KK, Johnson CA. Which method of flicker perimetry is most effective for detection of glaucomatous visual field loss? Invest Ophthalmol Vis Sci. 1997 Oct;38(11):2270-7.
- Background: PubMed 16637839Matsumoto C, Takada S, Okuyama S, Arimura E, Hashimoto S, Shimomura Y. Automated flicker perimetry in glaucoma using Octopus 311: a comparative study with the Humphrey Matrix. Acta Ophthalmol Scand. 2006 Apr;84(2):210-5. doi: 10.1111/j.1600-0420.2005.00588.x.
- Background: PubMed 2056646Tielsch JM, Sommer A, Katz J, Royall RM, Quigley HA, Javitt J. Racial variations in the prevalence of primary open-angle glaucoma. The Baltimore Eye Survey. JAMA. 1991 Jul 17;266(3):369-74.
- Background: PubMed 1922253Javitt JC, McBean AM, Nicholson GA, Babish JD, Warren JL, Krakauer H. Undertreatment of glaucoma among black Americans. N Engl J Med. 1991 Nov 14;325(20):1418-22. doi: 10.1056/NEJM199111143252005.
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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.
Colin Scott, MD principal investigator
Nassau University Medical Center
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 Northwell Health 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 2 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 15 Mar 2011. 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?
Difference of mean deviation of glaucoma suspects from controls between critical flicker fusion and automated visual fields. (time frame: 1 visit (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 NCT01076114, which also lists 11 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 15 Mar 2011.