GlaucomaNCT02547740
Macular Damage in Early Glaucoma and Progression
An observational study of Glaucoma, run by Columbia University at 1 site in United States.
Trial summary
Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 18 Jan 2024
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seen in Columbia eye clinics and enrolled in cross-sectional database; Columbia University Medical Center Eye Institute.
Who may be able to join
- glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria)
- best corrected visual acuity equal or better than 20/40
- normal biomicroscopy examination
- gonioscopically open angles
- Intraocular Pressure (IOP) lower than 22 mmHg
- normal and reliable 24-2 and 10-2 SAP results
Who cannot join
- late functional glaucomatous damage
- significant cataract
- previous ocular surgery (aside from uncomplicated cataract extraction with intraocular lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)
- diabetic retinopathy with macular edema
- vein or artery occlusion
- exudative age-related macular degeneration or geographic atrophy
Show all 18Show fewer
- macular hole or traction
- amblyopia
- uveitis
- non-open angle glaucoma (e.g. angle closure, traumatic, congenital glaucoma)
- severe myopia or hyperopia (refractive error greater than -6 or +6D, respectively)
- retinal detachment (current or post-surgery)
- retinitis pigmentosa
- significant epiretinal memberane
- significant kerotoconus
- Healthy Group:
- evidence of optic neuropathy
- evidence of clinically significant metabolic diseases (e.g. diabetes and hypotension)
Trial locations and contacts
1 site in 1 country.
United States1 site
CUIMC Harkness Eye Institute
New York, New York, 10032
About this study
Official title: Structural and Functional Progression of Glaucomatous Damage to the Macula
Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. There is scientific evidence that the macula, the central part of the retina, can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very prevalent and is often missed using conventional clinical tests.
Relatively little is known about progression of early glaucoma damage and its effects on the macula. This project investigates the nature of progressive damage to the macula and proposes new methods to improve accuracy to detect clinically significant progression.The study will evaluate the nature of damage to the macula's structures through OCT imaging and eye function via visual field tests.
Read the detailed description
There is compelling evidence that glaucomatous damage to the macula occurs even in early stages of the disease. The macula comprises about 30% of all retinal ganglion cells and its information corresponds to over 50% of the visual cortex. However, glaucomatous damage to the macula is often missed in clinical practice. Some of the reasons are:
- traditional glaucoma knowledge supports that glaucoma is fundamentally a peripheral disease;
- inherent limitations of conventional clinical tests to detect damage to the macula; and
- the paucity of large, prospective studies that describe the nature of glaucomatous damage to the macula.
The investigators have published numerous papers in the past two years showing that macular damage is prevalent among patients with early glaucoma if one employs the appropriate tools to assess it, namely 10-2 visual fields and high-resolution optical coherence tomography (OCT). This information comes from a unique prospective cross- sectional database and techniques the investigators developed to produce objective metrics of structure and function.
Now that the investigators understand the cross-sectional nature of macular damage, this proposal aims to:
- develop a longitudinal database including patients with early glaucoma and healthy controls,
- to test models that explain progression of macular damage, and
- to apply new statistical methods combining structural and functional tests which could improve the accuracy to detect progression and shorten the length of clinical trials.
The main hypothesis is that incorporating 10-2 visual field testing and high-resolution OCT scans of the macula to the conventional repertoire of technologies used in clinical practice, in addition to translating recently described statistical methods into softwares that can be used in daily practice, enhances the performance and confidence to detect glaucoma progression.
In Aim 1 the investigators plan to follow healthy subjects and glaucoma patients at regular intervals with 10-2, 24-2 visual fields, and swept source (ss) OCT tests and define metrics of short- and long-term test variability that are needed to differentiate true progression from 'noise'. To date, there is no such database combining these technologies.
In Aim 2 the investigators plan to combine metrics of structure and function from this longitudinal database using two methods: a spatial approach, which will ultimately produce a joint structure-function index using 10-2 and ssOCT data; and a temporal approach, which will employ Bayesian statistics to measure rates of progression using trend analysis. By the end of the study, our contributions to the field should be:
- to make available a unique and pristine longitudinal database that could be used for other hypotheses testing,
- to translate techniques recently described in the literature into objective tools to be readily useful in clinical practice, and
- to mitigate the burdens of progressive loss of central vision in glaucoma.
- Conditions
- Glaucoma
- Keywords
- macula, visual fields, optical coherence tomography, glaucoma progression, retinal ganglion cells
- 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 |
|---|---|---|
| Early Glaucomatous Damage | Patients with early functional glaucomatous damage. | |
| Ophthalmologically Healthy | Healthy subjects that are ophthalmologically normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10-2 visual field
Evidence of functional glaucomatous damage on the macula as confirmed by visual fields: A slope of 10-2 visual field change faster than -1 dB/year at P<5%
Measured: Baseline and 3 years
Change in macular ganglion cell thickness
Evidence of structural glaucomatous damage on the macula as confirmed by OCT imaging: evidence of macular ganglion cell thickness slope less than -10 microns/year
Measured: Baseline and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Liebmann, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547740
- Sponsor's protocol ID
- AAAO8502
- Other IDs
- 1R01EY025253-01
- Status last verified
- May 2024
- First submitted
- 10 Sep 2015
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hood DC, Tsamis E, Bommakanti NK, Joiner DB, Al-Aswad LA, Blumberg DM, Cioffi GA, Liebmann JM, De Moraes CG. Structure-Function Agreement Is Better Than Commonly Thought in Eyes With Early Glaucoma. Invest Ophthalmol Vis Sci. 2019 Oct 1;60(13):4241-4248. doi: 10.1167/iovs.19-27920.
PubMed 31618760
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Progression of Glaucomatous Damage to the Macula
- ClinicalTrials.gov ID
- NCT02547740
- Acronym / sponsor ID
- AAAO8502
- Conditions
- Glaucoma
- Keywords
- macula, visual fields, optical coherence tomography, glaucoma progression, retinal ganglion cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Oct 2015 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 11 Sep 2015 (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 the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. There is scientific evidence that the macula, the central part of the retina, can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very prevalent and is often missed using conventional clinical tests.
Relatively little is known about progression of early glaucoma damage and its effects on the macula. This project investigates the nature of progressive damage to the macula and proposes new methods to improve accuracy to detect clinically significant progression.The study will evaluate the nature of damage to the macula's structures through OCT imaging and eye function via visual field tests.
Detailed description
There is compelling evidence that glaucomatous damage to the macula occurs even in early stages of the disease. The macula comprises about 30% of all retinal ganglion cells and its information corresponds to over 50% of the visual cortex. However, glaucomatous damage to the macula is often missed in clinical practice. Some of the reasons are:
- traditional glaucoma knowledge supports that glaucoma is fundamentally a peripheral disease;
- inherent limitations of conventional clinical tests to detect damage to the macula; and
- the paucity of large, prospective studies that describe the nature of glaucomatous damage to the macula.
The investigators have published numerous papers in the past two years showing that macular damage is prevalent among patients with early glaucoma if one employs the appropriate tools to assess it, namely 10-2 visual fields and high-resolution optical coherence tomography (OCT). This information comes from a unique prospective cross- sectional database and techniques the investigators developed to produce objective metrics of structure and function.
Now that the investigators understand the cross-sectional nature of macular damage, this proposal aims to:
- develop a longitudinal database including patients with early glaucoma and healthy controls,
- to test models that explain progression of macular damage, and
- to apply new statistical methods combining structural and functional tests which could improve the accuracy to detect progression and shorten the length of clinical trials.
The main hypothesis is that incorporating 10-2 visual field testing and high-resolution OCT scans of the macula to the conventional repertoire of technologies used in clinical practice, in addition to translating recently described statistical methods into softwares that can be used in daily practice, enhances the performance and confidence to detect glaucoma progression.
In Aim 1 the investigators plan to follow healthy subjects and glaucoma patients at regular intervals with 10-2, 24-2 visual fields, and swept source (ss) OCT tests and define metrics of short- and long-term test variability that are needed to differentiate true progression from 'noise'. To date, there is no such database combining these technologies.
In Aim 2 the investigators plan to combine metrics of structure and function from this longitudinal database using two methods: a spatial approach, which will ultimately produce a joint structure-function index using 10-2 and ssOCT data; and a temporal approach, which will employ Bayesian statistics to measure rates of progression using trend analysis. By the end of the study, our contributions to the field should be:
- to make available a unique and pristine longitudinal database that could be used for other hypotheses testing,
- to translate techniques recently described in the literature into objective tools to be readily useful in clinical practice, and
- to mitigate the burdens of progressive loss of central vision in glaucoma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Glaucomatous Damage | – | –Patients with early functional glaucomatous damage. |
| Ophthalmologically Healthy | – | –Healthy subjects that are ophthalmologically normal |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in Columbia eye clinics and enrolled in cross-sectional database; Columbia University Medical Center Eye Institute.
Key inclusion criteria (6 listed)
- glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria)
- best corrected visual acuity equal or better than 20/40
- normal biomicroscopy examination
- gonioscopically open angles
- Intraocular Pressure (IOP) lower than 22 mmHg
Key exclusion criteria (18 listed)
- late functional glaucomatous damage
- significant cataract
- previous ocular surgery (aside from uncomplicated cataract extraction with intraocular lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)
- diabetic retinopathy with macular edema
- vein or artery occlusion
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
Change in 10-2 visual field
Time frame: Baseline and 3 years
Evidence of functional glaucomatous damage on the macula as confirmed by visual fields: A slope of 10-2 visual field change faster than -1 dB/year at P<5%
Change in macular ganglion cell thickness
Time frame: Baseline and 3 years
Evidence of structural glaucomatous damage on the macula as confirmed by OCT imaging: evidence of macular ganglion cell thickness slope less than -10 microns/year
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 14 May 2024.
- Derived from this study: PubMed 31618760Hood DC, Tsamis E, Bommakanti NK, Joiner DB, Al-Aswad LA, Blumberg DM, Cioffi GA, Liebmann JM, De Moraes CG. Structure-Function Agreement Is Better Than Commonly Thought in Eyes With Early Glaucoma. Invest Ophthalmol Vis Sci. 2019 Oct 1;60(13):4241-4248. doi: 10.1167/iovs.19-27920.
- 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.
Jeffrey Liebmann, MD principal investigator
Columbia University
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 Columbia University 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 18 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 14 May 2024. 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?
Change in 10-2 visual field (time frame: Baseline and 3 years). The study lists 2 primary outcomes in all. 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 NCT02547740, which also lists 1 linked publication.
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 14 May 2024.