Primary Open Angle GlaucomaSTR_FNNCT02028572
Structure Function Correlation in Primary Open Angle Glaucoma
An observational study of Primary Open Angle Glaucoma, run by Vasan Eye Care Hospital at 1 site in India.
Trial summary
Glaucoma is an optic neuropathy characterised by progressive degeneration of retinal ganglion cells and axons that leads to nerve fibre loss, optic disc cupping, and consecutive glaucomatous visual field defects. It is considered to be one of the major causes of blindness worldwide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 130 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2013to Jun 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects presenting to the glaucoma clinic of a tertiary eye care hospital an diagnosed to have primary open angle glaucoma
Who may be able to join
- Subjects visiting a glaucoma clinic diagnosed with primary open - angle glaucoma.
- Subjects should have best corrected visual acuity not less than 6/18.
- Refractive spherical error within the range of -6.00 dioptres to + 3.00 dioptres and cylindrical error within +/- 2.5 dioptres.
- Visual fields examination of the subjects demonstrating field defects secondary to glaucomatous damage with mean deviation ranging from -2 to -10 decibels (db).
- The visual fields of the subjects should be within the reliability criteria (<20% fixation losses, false positives and false negatives).
- The signal to noise ratio for a reliable Optical Coherence Tomograph - Retinal Nerve Fibre Layer scan shall not be less than 6.
Who cannot join
- History of (H/O) retinal disease or photocoagulation.
- H/O ocular trauma or surgery except an uncomplicated cataract surgery.
- H/O other optic nerve disease except glaucoma
- H/O amblyopia
- Neurological disease which can affect visual fields.
- Visually significant cataracts (Posterior Subcapsular Cataracts, > N.S Grade II).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross Sectional Study of Correlation Between Retinal Nerve Fibre Thickness Measured by Optical Coherence Tomography and Humphrey Visual Fields in Early and Moderate Open Angle Glaucoma
Glaucoma is an optic neuropathy characterised by progressive degeneration of retinal ganglion cells and axons that leads to nerve fibre loss, optic disc cupping, and consecutive glaucomatous visual field defects. It is considered to be one of the major causes of blindness worldwide.
It is a well accepted fact least 25 - 40% of retinal ganglion cells need to be lost before statistically detectable visual field defects appear on automated visual field testing, which is also consistent with post-mortem histologic findings in glaucomatous eyes. Since the damage associated with glaucoma is irreversible, and retinal nerve fibre layer loss is considered as an early sign of glaucomatous damage, its early detection and prevention is warranted. Retinal nerve fibre layer studies can be undertaken through non - invasive, reproducible technologies such as optical coherence tomography, scanning laser polarimetry etc.
The purpose of the study is to evaluate the relationship between visual fields and retinal nerve fibre layer thickness as measured by Cirrus spectral domain optical coherence tomography with visual fields by Humphrey Field Analyser (HFA) in early and moderate primary open - angle glaucoma.
Read the detailed description
It is often said that the structural damage due to glaucoma precedes functional loss, it is not always clear in its interpretation. To define, which test shows up the earliest sign of glaucomatous damage would be difficult to predict, since the outcome can be influenced by many factors, such as the sensitivity of the test, inter - individual difference or the stage of the disease process itself. Studies on post-mortem retinal ganglion cells counts and SAP field loss in humans and monkeys lead to an observation that, on an average about 25% retinal ganglion cells loss leads to development of an afferent pupillary defect, 35% loss for visual field defects and 40% loss leads to worsening of visual acuity. It would be safe to state that a) the most important clinical challenge is early detection of glaucomatous damage and progression over a period of time; b) Both structural and functional tests are important in assessing early damage and progression; c) significant damage to the retinal ganglion cells can occur before standard tests detect a functional loss in vision. These have paved the way to the development of many studies on the structure - function correlation and stating linear models for the same. However these studies present a dilemma; is the structure - function relation on glaucoma, a statistical statement (a structural measure will reach significance before a functional test) or relational statement (statistical correlation between the structural and functional tests).
We propose to evaluate the structure - function correlation in early and moderate open - angle glaucoma by assessing the retinal nerve fibre layer thickness by Spectral Domain Optical Coherence Tomography and areas of decreased visual field sensitivity given by Humphrey 24 - 2 Swedish Interactive Threshold Algorithm Standard protocol of automated perimetry and determine any representational or statistical significance, if any between the two tests.
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Structure function correlation, Optical coherence tomography, Retinal Nerve fibre layer thickness, Visual fields, Primary open angle glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
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 |
|---|---|---|
| Primary open angle glaucoma | Subjects diagnosed to have primary open angle glaucoma with intraocular pressure > 21 mm Hg and characteristic glaucomatous damage to the optic nerve. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between retinal nerve fibre layer thickness measured by optical coherence tomography and mean sensitivity, mean deviation as reported by visual fields.
Measured: The subjects shall be studied over an avergae period of 4 weeks from the presentation for the purpose of optical coherence tomography and visual field studies.
Secondary outcomes (1)
Correlation between retinal nerve fibre layer thinning and scotomatous defects in visual fields in primary open angle glaucoma.
Measured: The subjects shall be reviewed over an average period of 4 weeks to obtain the optical coherence tomography and visual field studies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vasan Eye Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.ANAND PARTHASARATHY, Dr. Ramesh Hariharan, Vasan Eye Care Hospital
- Investigators
- Dr.Venkatesh Sugantharaj, MS, DNB, Study director, Vasan Eye Care HospitalDr.RAMESH HARIHARAN, MBBS,DNB, Principal investigator, Vasan Eye Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028572
- Sponsor's protocol ID
- GLC-STR-FN
- Acronym
- STR_FN
- Status last verified
- Dec 2014
- First submitted
- 5 Dec 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hood DC, Kardon RH. A framework for comparing structural and functional measures of glaucomatous damage. Prog Retin Eye Res. 2007 Nov;26(6):688-710. doi: 10.1016/j.preteyeres.2007.08.001. Epub 2007 Aug 21.
PubMed 17889587El Beltagi TA, Bowd C, Boden C, Amini P, Sample PA, Zangwill LM, Weinreb RN. Retinal nerve fiber layer thickness measured with optical coherence tomography is related to visual function in glaucomatous eyes. Ophthalmology. 2003 Nov;110(11):2185-91. doi: 10.1016/S0161-6420(03)00860-1.
PubMed 14597528Ajtony C, Balla Z, Somoskeoy S, Kovacs B. Relationship between visual field sensitivity and retinal nerve fiber layer thickness as measured by optical coherence tomography. Invest Ophthalmol Vis Sci. 2007 Jan;48(1):258-63. doi: 10.1167/iovs.06-0410.
PubMed 17197541
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study of Correlation Between Retinal Nerve Fibre Thickness Measured by Optical Coherence Tomography and Humphrey Visual Fields in Early and Moderate Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02028572
- Acronym / sponsor ID
- STR_FN / GLC-STR-FN
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Structure function correlation, Optical coherence tomography, Retinal Nerve fibre layer thickness, Visual fields, Primary open angle glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Vasan Eye Care HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Jan 2014 (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.
Glaucoma is an optic neuropathy characterised by progressive degeneration of retinal ganglion cells and axons that leads to nerve fibre loss, optic disc cupping, and consecutive glaucomatous visual field defects. It is considered to be one of the major causes of blindness worldwide.
It is a well accepted fact least 25 - 40% of retinal ganglion cells need to be lost before statistically detectable visual field defects appear on automated visual field testing, which is also consistent with post-mortem histologic findings in glaucomatous eyes. Since the damage associated with glaucoma is irreversible, and retinal nerve fibre layer loss is considered as an early sign of glaucomatous damage, its early detection and prevention is warranted. Retinal nerve fibre layer studies can be undertaken through non - invasive, reproducible technologies such as optical coherence tomography, scanning laser polarimetry etc.
The purpose of the study is to evaluate the relationship between visual fields and retinal nerve fibre layer thickness as measured by Cirrus spectral domain optical coherence tomography with visual fields by Humphrey Field Analyser (HFA) in early and moderate primary open - angle glaucoma.
Detailed description
It is often said that the structural damage due to glaucoma precedes functional loss, it is not always clear in its interpretation. To define, which test shows up the earliest sign of glaucomatous damage would be difficult to predict, since the outcome can be influenced by many factors, such as the sensitivity of the test, inter - individual difference or the stage of the disease process itself. Studies on post-mortem retinal ganglion cells counts and SAP field loss in humans and monkeys lead to an observation that, on an average about 25% retinal ganglion cells loss leads to development of an afferent pupillary defect, 35% loss for visual field defects and 40% loss leads to worsening of visual acuity. It would be safe to state that a) the most important clinical challenge is early detection of glaucomatous damage and progression over a period of time; b) Both structural and functional tests are important in assessing early damage and progression; c) significant damage to the retinal ganglion cells can occur before standard tests detect a functional loss in vision. These have paved the way to the development of many studies on the structure - function correlation and stating linear models for the same. However these studies present a dilemma; is the structure - function relation on glaucoma, a statistical statement (a structural measure will reach significance before a functional test) or relational statement (statistical correlation between the structural and functional tests).
We propose to evaluate the structure - function correlation in early and moderate open - angle glaucoma by assessing the retinal nerve fibre layer thickness by Spectral Domain Optical Coherence Tomography and areas of decreased visual field sensitivity given by Humphrey 24 - 2 Swedish Interactive Threshold Algorithm Standard protocol of automated perimetry and determine any representational or statistical significance, if any between the two tests.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary open angle glaucoma | – | –Subjects diagnosed to have primary open angle glaucoma with intraocular pressure > 21 mm Hg and characteristic glaucomatous damage to the optic nerve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting to the glaucoma clinic of a tertiary eye care hospital an diagnosed to have primary open angle glaucoma
Key inclusion criteria (6 listed)
- Subjects visiting a glaucoma clinic diagnosed with primary open - angle glaucoma.
- Subjects should have best corrected visual acuity not less than 6/18.
- Refractive spherical error within the range of -6.00 dioptres to + 3.00 dioptres and cylindrical error within +/- 2.5 dioptres.
- Visual fields examination of the subjects demonstrating field defects secondary to glaucomatous damage with mean deviation ranging from -2 to -10 decibels (db).
- The visual fields of the subjects should be within the reliability criteria (<20% fixation losses, false positives and false negatives).
Key exclusion criteria (6 listed)
- History of (H/O) retinal disease or photocoagulation.
- H/O ocular trauma or surgery except an uncomplicated cataract surgery.
- H/O other optic nerve disease except glaucoma
- H/O amblyopia
- Neurological disease which can affect visual fields.
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
Correlation between retinal nerve fibre layer thickness measured by optical coherence tomography and mean sensitivity, mean deviation as reported by visual fields.
Time frame: The subjects shall be studied over an avergae period of 4 weeks from the presentation for the purpose of optical coherence tomography and visual field studies.
1 secondary outcome
Correlation between retinal nerve fibre layer thinning and scotomatous defects in visual fields in primary open angle glaucoma.
Time frame: The subjects shall be reviewed over an average period of 4 weeks to obtain the optical coherence tomography and visual field studies.
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 30 Dec 2014.
- Background: PubMed 17889587Hood DC, Kardon RH. A framework for comparing structural and functional measures of glaucomatous damage. Prog Retin Eye Res. 2007 Nov;26(6):688-710. doi: 10.1016/j.preteyeres.2007.08.001. Epub 2007 Aug 21.
- Background: PubMed 14597528El Beltagi TA, Bowd C, Boden C, Amini P, Sample PA, Zangwill LM, Weinreb RN. Retinal nerve fiber layer thickness measured with optical coherence tomography is related to visual function in glaucomatous eyes. Ophthalmology. 2003 Nov;110(11):2185-91. doi: 10.1016/S0161-6420(03)00860-1.
- Background: PubMed 17197541Ajtony C, Balla Z, Somoskeoy S, Kovacs B. Relationship between visual field sensitivity and retinal nerve fiber layer thickness as measured by optical coherence tomography. Invest Ophthalmol Vis Sci. 2007 Jan;48(1):258-63. doi: 10.1167/iovs.06-0410.
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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.
Dr.Venkatesh Sugantharaj, MS, DNB study director
Vasan Eye Care Hospital
Dr.RAMESH HARIHARAN, MBBS,DNB principal investigator
Vasan Eye Care 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 Primary Open Angle Glaucoma, run by Vasan Eye Care Hospital at 1 site in India.
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 6 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 30 Dec 2014. 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 India. 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?
Correlation between retinal nerve fibre layer thickness measured by optical coherence tomography and mean sensitivity, mean deviation as reported by visual fields. (time frame: The subjects shall be studied over an avergae period of 4 weeks from the presentation for the purpose of optical coherence tomography and visual field studies.). 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 NCT02028572, which also lists 3 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 30 Dec 2014.