Diagnostic Innovations in Glaucoma Study

Myopia Clinical Trial

— DIGS  

Official title:

Diagnostic Innovations in Glaucoma Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00221897
• Other study ID #: EY08208; EY11008, EY027510
• Secondary ID: R01EY027510
• Status: Recruiting
• Start date: April 1995
• Est. completion date: July 2022

Study information

• Verified date: July 2021
• Source: University of California, San Diego
• Contact: Eunice Williams-Steppe, MA
• Phone: 858-822-1133
• Email: ewsteppe[@]glaucoma.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 20/40 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion:

• Subjects are healthy controls with or without myopia, and patients with or without myopia with a diagnosis of glaucoma, glaucoma suspect and ocular hypertension

• They will be considered if they are above 18 years old.

• There is no upper age limit

• Subject are not restricted by gender, race or ethnicity.

Exclusion:

-Participants with other ocular or systemic conditions and treatment, which may affect visual function, are excluded.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Myopia
• Primary Open Angle Glaucoma

Locations

Country	Name	City	State
United States	UCSD, Hamilton Glaucoma Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (37)

Akagi T, Zangwill LM, Saunders LJ, Yarmohammadi A, Manalastas PIC, Suh MH, Girkin CA, Liebmann JM, Weinreb RN. Rates of Local Retinal Nerve Fiber Layer Thinning before and after Disc Hemorrhage in Glaucoma. Ophthalmology. 2017 Sep;124(9):1403-1411. doi: 1 — View Citation

Belghith A, Medeiros FA, Bowd C, Liebmann JM, Girkin CA, Weinreb RN, Zangwill LM. Structural Change Can Be Detected in Advanced-Glaucoma Eyes. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT511-8. doi: 10.1167/iovs.15-18929. — View Citation

Bowd C, Zangwill LM, Medeiros FA, Hao J, Chan K, Lee TW, Sejnowski TJ, Goldbaum MH, Sample PA, Crowston JG, Weinreb RN. Confocal scanning laser ophthalmoscopy classifiers and stereophotograph evaluation for prediction of visual field abnormalities in glau — View Citation

Bowd C, Zangwill LM, Weinreb RN, Medeiros FA, Belghith A. Estimating Optical Coherence Tomography Structural Measurement Floors to Improve Detection of Progression in Advanced Glaucoma. Am J Ophthalmol. 2017 Mar;175:37-44. doi: 10.1016/j.ajo.2016.11.010. — View Citation

De Moraes CG, Hood DC, Thenappan A, Girkin CA, Medeiros FA, Weinreb RN, Zangwill LM, Liebmann JM. 24-2 Visual Fields Miss Central Defects Shown on 10-2 Tests in Glaucoma Suspects, Ocular Hypertensives, and Early Glaucoma. Ophthalmology. 2017 Oct;124(10):1 — View Citation

De Moraes CG, Murphy JT, Kaplan CM, Reimann JJ, Skaat A, Blumberg DM, Al-Aswad L, Cioffi GA, Girkin CA, Medeiros FA, Weinreb RN, Zangwill L, Liebmann JM. ß-Zone Parapapillary Atrophy and Rates of Glaucomatous Visual Field Progression: African Descent and — View Citation

Diniz-Filho A, Abe RY, Zangwill LM, Gracitelli CP, Weinreb RN, Girkin CA, Liebmann JM, Medeiros FA. Association between Intraocular Pressure and Rates of Retinal Nerve Fiber Layer Loss Measured by Optical Coherence Tomography. Ophthalmology. 2016 Oct;123( — View Citation

Gracitelli CP, Tatham AJ, Zangwill LM, Weinreb RN, Abe RY, Diniz-Filho A, Paranhos A Jr, Baig S, Medeiros FA. Asymmetric Macular Structural Damage Is Associated With Relative Afferent Pupillary Defects in Patients With Glaucoma. Invest Ophthalmol Vis Sci. — View Citation

Hammel N, Belghith A, Bowd C, Medeiros FA, Sharpsten L, Mendoza N, Tatham AJ, Khachatryan N, Liebmann JM, Girkin CA, Weinreb RN, Zangwill LM. Rate and Pattern of Rim Area Loss in Healthy and Progressing Glaucoma Eyes. Ophthalmology. 2016 Apr;123(4):760-70 — View Citation

Hammel N, Belghith A, Weinreb RN, Medeiros FA, Mendoza N, Zangwill LM. Comparing the Rates of Retinal Nerve Fiber Layer and Ganglion Cell-Inner Plexiform Layer Loss in Healthy Eyes and in Glaucoma Eyes. Am J Ophthalmol. 2017 Jun;178:38-50. doi: 10.1016/j. — View Citation

Kabbara SW, Zangwill LM, Mundae R, Hammel N, Bowd C, Medeiros FA, Weinreb RN, Belghith A. Comparing optical coherence tomography radial and cube scan patterns for measuring Bruch's membrane opening minimum rim width (BMO-MRW) in glaucoma and healthy eyes: — View Citation

Medeiros FA, Sample PA, Weinreb RN. Frequency doubling technology perimetry abnormalities as predictors of glaucomatous visual field loss. Am J Ophthalmol. 2004 May;137(5):863-71. — View Citation

Medeiros FA, Zangwill LM, Bowd C, Vessani RM, Susanna R Jr, Weinreb RN. Evaluation of retinal nerve fiber layer, optic nerve head, and macular thickness measurements for glaucoma detection using optical coherence tomography. Am J Ophthalmol. 2005 Jan;139( — View Citation

Medeiros FA, Zangwill LM, Bowd C, Weinreb RN. Comparison of the GDx VCC scanning laser polarimeter, HRT II confocal scanning laser ophthalmoscope, and stratus OCT optical coherence tomograph for the detection of glaucoma. Arch Ophthalmol. 2004 Jun;122(6): — View Citation

Mohammadi K, Bowd C, Weinreb RN, Medeiros FA, Sample PA, Zangwill LM. Retinal nerve fiber layer thickness measurements with scanning laser polarimetry predict glaucomatous visual field loss. Am J Ophthalmol. 2004 Oct;138(4):592-601. — View Citation

Sample PA, Chan K, Boden C, Lee TW, Blumenthal EZ, Weinreb RN, Bernd A, Pascual J, Hao J, Sejnowski T, Goldbaum MH. Using unsupervised learning with variational bayesian mixture of factor analysis to identify patterns of glaucomatous visual field defects. — View Citation

Sample PA, Weinreb RN, Boynton RM. Acquired dyschromatopsia in glaucoma. Surv Ophthalmol. 1986 Jul-Aug;31(1):54-64. Review. — View Citation

Saunders LJ, Medeiros FA, Weinreb RN, Zangwill LM. What rates of glaucoma progression are clinically significant? Expert Rev Ophthalmol. 2016;11(3):227-234. doi: 10.1080/17469899.2016.1180246. Epub 2016 May 13. — View Citation

Shoji T, Zangwill LM, Akagi T, Saunders LJ, Yarmohammadi A, Manalastas PIC, Penteado RC, Weinreb RN. Progressive Macula Vessel Density Loss in Primary Open-Angle Glaucoma: A Longitudinal Study. Am J Ophthalmol. 2017 Oct;182:107-117. doi: 10.1016/j.ajo.201 — View Citation

Silverman AL, Hammel N, Khachatryan N, Sharpsten L, Medeiros FA, Girkin CA, Liebmann JM, Weinreb RN, Zangwill LM. Diagnostic Accuracy of the Spectralis and Cirrus Reference Databases in Differentiating between Healthy and Early Glaucoma Eyes. Ophthalmolog — View Citation

Skaat A, De Moraes CG, Bowd C, Sample PA, Girkin CA, Medeiros FA, Ritch R, Weinreb RN, Zangwill LM, Liebmann JM; Diagnostic Innovations in Glaucoma Study and African Descent and Glaucoma Evaluation Study Groups. African Descent and Glaucoma Evaluation Stu — View Citation

Stamper R. L., Sample P. A. and Girkin C. A. (Eds.). (2003). Assessing Visual Function in Clinical Practice. Ophthalmology Clinics of North America, Vol.16, Number 2. In Anderson D.R.(ed.) Standard Perimetry (pp. 205-212).

Stamper R. L., Sample P. A. and Girkin C. A. (Eds.). (2003). Assessing Visual Function in Clinical Practice. Ophthalmology Clinics of North America, Vol.16, Number 2. In Anderson J.A and Johnson C.A. (eds.). Frequency-Doubling Technology Perminetry (pp. 2

Stamper R. L., Sample P. A. and Girkin C. A. (Eds.). (2003). Assessing Visual Function in Clinical Practice. Ophthalmology Clinics of North America, Vol.16, Number 2. In Racette L and Sample P.A. (eds.). Short wave automated perimetry. (pp. 227 -236).

Suh MH, Zangwill LM, Manalastas PI, Belghith A, Yarmohammadi A, Medeiros FA, Diniz-Filho A, Saunders LJ, Weinreb RN. Deep Retinal Layer Microvasculature Dropout Detected by the Optical Coherence Tomography Angiography in Glaucoma. Ophthalmology. 2016 Dec; — View Citation

Suh MH, Zangwill LM, Manalastas PI, Belghith A, Yarmohammadi A, Medeiros FA, Diniz-Filho A, Saunders LJ, Yousefi S, Weinreb RN. Optical Coherence Tomography Angiography Vessel Density in Glaucomatous Eyes with Focal Lamina Cribrosa Defects. Ophthalmology. — View Citation

Weinreb R.N. and Greve E.L. (Eds.). (2004). Glaucoma diagnosis. Structure and function. The Hague, The Netherlands: Kugler Publications.

Wu Z, Saunders LJ, Zangwill LM, Daga FB, Crowston JG, Medeiros FA. Impact of Normal Aging and Progression Definitions on the Specificity of Detecting Retinal Nerve Fiber Layer Thinning. Am J Ophthalmol. 2017 Sep;181:106-113. doi: 10.1016/j.ajo.2017.06.017 — View Citation

Yarmohammadi A, Zangwill LM, Diniz-Filho A, Saunders LJ, Suh MH, Wu Z, Manalastas PIC, Akagi T, Medeiros FA, Weinreb RN. Peripapillary and Macular Vessel Density in Patients with Glaucoma and Single-Hemifield Visual Field Defect. Ophthalmology. 2017 May;1 — View Citation

Yarmohammadi A, Zangwill LM, Diniz-Filho A, Suh MH, Manalastas PI, Fatehee N, Yousefi S, Belghith A, Saunders LJ, Medeiros FA, Huang D, Weinreb RN. Optical Coherence Tomography Angiography Vessel Density in Healthy, Glaucoma Suspect, and Glaucoma Eyes. In — View Citation

Yarmohammadi A, Zangwill LM, Diniz-Filho A, Suh MH, Yousefi S, Saunders LJ, Belghith A, Manalastas PI, Medeiros FA, Weinreb RN. Relationship between Optical Coherence Tomography Angiography Vessel Density and Severity of Visual Field Loss in Glaucoma. Oph — View Citation

Yarmohammadi A, Zangwill LM, Weinreb RN. Reply. Ophthalmology. 2017 May;124(5):e51. doi: 10.1016/j.ophtha.2016.11.031. — View Citation

Yousefi S, Balasubramanian M, Goldbaum MH, Medeiros FA, Zangwill LM, Weinreb RN, Liebmann JM, Girkin CA, Bowd C. Unsupervised Gaussian Mixture-Model With Expectation Maximization for Detecting Glaucomatous Progression in Standard Automated Perimetry Visua — View Citation

Zangwill LM, Abunto T, Bowd C, Angeles R, Schanzlin DJ, Weinreb RN. Scanning laser polarimetry retinal nerve fiber layer thickness measurements after LASIK. Ophthalmology. 2005 Feb;112(2):200-7. — View Citation

Zangwill LM, Chan K, Bowd C, Hao J, Lee TW, Weinreb RN, Sejnowski TJ, Goldbaum MH. Heidelberg retina tomograph measurements of the optic disc and parapapillary retina for detecting glaucoma analyzed by machine learning classifiers. Invest Ophthalmol Vis S — View Citation

Zhang C, Tatham AJ, Abe RY, Diniz-Filho A, Zangwill LM, Weinreb RN, Medeiros FA. Corneal Hysteresis and Progressive Retinal Nerve Fiber Layer Loss in Glaucoma. Am J Ophthalmol. 2016 Jun;166:29-36. doi: 10.1016/j.ajo.2016.02.034. Epub 2016 Mar 3. — View Citation

Zhang C, Tatham AJ, Abe RY, Hammel N, Belghith A, Weinreb RN, Medeiros FA, Liebmann JM, Girkin CA, Zangwill LM. Macular Ganglion Cell Inner Plexiform Layer Thickness in Glaucomatous Eyes with Localized Retinal Nerve Fiber Layer Defects. PLoS One. 2016 Aug — View Citation

* Note: There are 37 references in all — Click here to view all references

External Links

•   Official website at UCSD