Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221897
Status:
UNKNOWN
Last Update Posted:
2021-07-06
First Post:
2005-09-14
Brief Title:
Diagnostic Innovations in Glaucoma Study
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Diagnostic Innovations in Glaucoma Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIGS
Brief Summary:
The overarching goal of our research study is to evaluate changes in visual function and optic nerve topography the structure of the back of the eye in patients with glaucoma increased susceptibility to pressure inside the eye that can cause loss of vision or those with an increased risk of developing the disease The purpose of this study is to determine the best methods for detecting the presence or progression worsening over time of glaucoma in patients with and without myopia and its effects on daily and visual function and quality of life With several sources of NIH and foundation funding over the last twenty years we have designed a robust research protocol to address the most challenging aspects of glaucoma management The most recent focus of this research is 1 to improve our ability to detect open angle glaucoma in individuals with myopia and in individuals of European and African descent 2 to determine whether monitoring of the retinal vasculature with new optical imaging instruments can improve glaucoma management and elucidate the pathophysiology of the disease and 3 to differentiate between age-related changes and glaucomatous progression
The grants supporting this project include 3 NIH funded studies 1 the University of California San Diego UCSD -based Diagnostic Innovations in Glaucoma Study DIGS funded since 1995 2 the African Descent and Glaucoma Evaluation Study ADAGES funded since 2002 3 the Brightfocus Foundation National Glaucoma Research Program and 4 the UCSD-based Diagnosis and Monitoring of Glaucoma with Optical Coherence Tomography Angiography funded since 2018 The ADAGES is a multi-center study with data collection also conducted at 2 other academic sites the University of Alabama at Birmingham and Columbia University
Enrolled healthy participants glaucoma suspects and glaucoma patients are generally asked to return for two or more visits a year for several years We then analyze whether the glaucoma patients are progressing and what factors influence their glaucoma status compared to healthy subjects and individuals suspected of having glaucoma
The grants supporting this project include 3 NIH funded studies 1 the University of California San Diego UCSD -based Diagnostic Innovations in Glaucoma Study DIGS funded since 1995 2 the African Descent and Glaucoma Evaluation Study ADAGES funded since 2002 3 the Brightfocus Foundation National Glaucoma Research Program and 4 the UCSD-based Diagnosis and Monitoring of Glaucoma with Optical Coherence Tomography Angiography funded since 2018 The ADAGES is a multi-center study with data collection also conducted at 2 other academic sites the University of Alabama at Birmingham and Columbia University
Enrolled healthy participants glaucoma suspects and glaucoma patients are generally asked to return for two or more visits a year for several years We then analyze whether the glaucoma patients are progressing and what factors influence their glaucoma status compared to healthy subjects and individuals suspected of having glaucoma
Detailed Description:
The Diagnostic Innovation in Glaucoma Study DIGS and ADAGES are longitudinal studies in which participants with or without myopia are examined approximately biannually in most cases Healthy controls with or without myopia are examined once in most cases The ADAGES recruitment and testing of individuals of African descent is an independently funded multi-center including UCSD Columbia University and University of Alabama Birmingham study which follows the same study protocol as the DIGS to ensure that the data from both studies can be analyzed together This harmonization of protocols leverages the advantages of both DIGS by increasing the sample sizes to address the unique hypotheses of each study
All participants must be 18 years old or older Participants with or without myopia will be required to have at least one eye with open angles best corrected visual acuity of 2040 or better to be included Participants taking a medication known to affect visual field sensitivity and eyes with a history of intraocular surgery except uncomplicated glaucoma and cataract surgery a secondary cause of elevated intraocular pressure a coexisting intraocular disease affecting visual field or a problem other than glaucoma affecting color vision may be excluded
Most of the extensive testing completed for these visits can be considered standard of care but for clinical care all tests are not generally all done at the same patient visit with the variety of instruments included in this research project The following tests can be considered standard of care medical history blood pressure and heart rate height and weight visual acuity testing near acuity testing low contrast sensitivity testing slit lamp biomicroscopy including gonioscopy measurements of intraocular pressure with contact and non-contact tonometry corneal thickness measurement pachymetry corneal elasticity measured using non-contact tonometry interocular axial length corneal curvature anterior chamber depth measurements all measured using intraocular lens IOL master dilated fundoscopy stereoscopic ophthalmoscopy of the optic disc with a 78 D lens color vision testing standard automated perimetry optical coherence tomography OCT and photography
There is currently no end date to the study as the follow-up will continue as long as the research is supported
The time involved is usually 2-4 visits per year of approximately 2-5 hours each
DIGS Positional Study Subjects will also be given the opportunity to participate in the following additional auxiliary study The DIGS Positional Study will allow subjects to participate in an ancillary study Participation in this ancillary study includes imaging of the eyes using Optical Coherence Tomography OCT and Optical Coherence Tomography Angiography OCT-A as well as measurement of intraocular pressure IOP and blood pressure BP in sitting and supine positions No invasive procedures or treatments will be administered We will be using the standard clinically available software as well as investigational software available for research purposes The investigational software has been deemed safe by the manufacturer of the device and does not pose any additional risks to patients Since not every glaucoma patient has high eye pressure low-tension glaucoma or has pressure controlled with medication use so that the untreated eye pressure is now known glaucoma subjects using intraocular pressure lowering medication and with IOP 25 mm Hg may be requested to stop their medication for 1 to 3 weeks by the treating ophthalmologist depending on the class of medication before being imaged Risks are small and include IOP elevation However glaucoma progression is on the order of months to years and not days Subjects will resume using the medication after the research visit is completed
All participants must be 18 years old or older Participants with or without myopia will be required to have at least one eye with open angles best corrected visual acuity of 2040 or better to be included Participants taking a medication known to affect visual field sensitivity and eyes with a history of intraocular surgery except uncomplicated glaucoma and cataract surgery a secondary cause of elevated intraocular pressure a coexisting intraocular disease affecting visual field or a problem other than glaucoma affecting color vision may be excluded
Most of the extensive testing completed for these visits can be considered standard of care but for clinical care all tests are not generally all done at the same patient visit with the variety of instruments included in this research project The following tests can be considered standard of care medical history blood pressure and heart rate height and weight visual acuity testing near acuity testing low contrast sensitivity testing slit lamp biomicroscopy including gonioscopy measurements of intraocular pressure with contact and non-contact tonometry corneal thickness measurement pachymetry corneal elasticity measured using non-contact tonometry interocular axial length corneal curvature anterior chamber depth measurements all measured using intraocular lens IOL master dilated fundoscopy stereoscopic ophthalmoscopy of the optic disc with a 78 D lens color vision testing standard automated perimetry optical coherence tomography OCT and photography
There is currently no end date to the study as the follow-up will continue as long as the research is supported
The time involved is usually 2-4 visits per year of approximately 2-5 hours each
DIGS Positional Study Subjects will also be given the opportunity to participate in the following additional auxiliary study The DIGS Positional Study will allow subjects to participate in an ancillary study Participation in this ancillary study includes imaging of the eyes using Optical Coherence Tomography OCT and Optical Coherence Tomography Angiography OCT-A as well as measurement of intraocular pressure IOP and blood pressure BP in sitting and supine positions No invasive procedures or treatments will be administered We will be using the standard clinically available software as well as investigational software available for research purposes The investigational software has been deemed safe by the manufacturer of the device and does not pose any additional risks to patients Since not every glaucoma patient has high eye pressure low-tension glaucoma or has pressure controlled with medication use so that the untreated eye pressure is now known glaucoma subjects using intraocular pressure lowering medication and with IOP 25 mm Hg may be requested to stop their medication for 1 to 3 weeks by the treating ophthalmologist depending on the class of medication before being imaged Risks are small and include IOP elevation However glaucoma progression is on the order of months to years and not days Subjects will resume using the medication after the research visit is completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01EY027510 | NIH | None | httpsreporternihgovquickSearchR01EY027510 |