Advanced Imaging for Glaucoma Study

NCT01314326 | Completed DMC

• 2 other identifiers: OHSU IRB #00006611 - AIGSR01EY013516
• Study Type: observational
• Target: 832
• Locations: 1 country
• Sites: 5

Brief Summary

The specific aims of the clinical studies are to:

1. 1.Predict the development of glaucomatous visual field (VF) abnormality in glaucoma suspects and pre-perimetric glaucoma patients based on anatomic abnormalities detected by advanced imaging.
2. 2.Predict the development of glaucomatous VF abnormality in glaucoma suspects and pre-perimetric glaucoma patients based on anatomic changes detected between successive advanced imaging tests.
3. 3.Determine the sensitivity and specificity of glaucoma diagnosis based on advanced imaging tests.

Conditions

Glaucoma

Keywords

Optical Coherence Tomography; Glaucoma; Advanced Imaging

Outcome Measures

Primary Outcomes (1)

• Developing glaucoma or progression with glaucoma as defined by study criteria

  5 years or the end of the study

Study Arms (3)

Perimetric Glaucoma (PG)

Patients with clinically confirmed abnormal VF and glaucomatous ONH or NFL defect

Glaucoma Suspects and Pre-Perimetric Glaucoma (GSPPG) Group

Patients who are at high risk to develop perimetric glaucoma

Normal Group

Volunteers with healthy eyes

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll both males and females and include all ethnic and racial groups through clinical practices in the centers. The study will enroll subjects in the older adult age range commonly affected by glaucoma - 40 years or older. The study will exclude people with life-threatening or debilitating illness that would make 5-year participation unlikely or cooperation with tests difficult. For similar reasons those older than 79 years are excluded. The study also excludes those with any disease that might confound the diagnosis of glaucoma. Otherwise people with any health status are eligible for enrollment. Three groups of participants are recruited in the AIG study: normal (N), glaucoma suspects \& preperimetric glaucoma (GSPPG) and perimetric glaucoma (PG).

You may qualify if:

• No history of glaucoma, retinal pathology, keratorefractive surgery, or corticosteroid use.
• Normal visual field (VF), intraocular pressure (IOP), optic nerve head and nerve fiber layer.
• Central pachymetry \> 500 μm.
• Open angle.
• Ocular hypertension, defined as IOP ≥ 24 mmHg in one eye and IOP ≥ 22 mmHg in the fellow eye, on or off glaucoma medications.
• Optic nerve head (ONH) or nerve fiber layer (NFL) defect visible on slit-lamp biomicroscopy and stereo color fundus photography as defined for the PG group.
• The fellow eye meeting the eligibility criteria for the PG group.
• GSPPG eyes must not have an abnormal VF as defined for the PG group.
• GSPPG participants having glaucomatous ONH or NFL defect are subclassified as PPG; the remainder are subclassified as GS.
• Abnormal VF and
• Glaucomatous ONH of NFL defect.

You may not qualify if:

• Best corrected visual acuity worse than 20/40.
• Age \< 40 or \> 79 years.
• Refractive error \> +3.0D or \< -7.0 D.
• Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber IOL implantation.
• Diabetic retinopathy or other disease that may cause visual field loss or optic disc abnormalities.
• Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil.
• Inability to obtain advanced imaging data with acceptable quality or reliable VF test results.
• Life-threatening or debilitating illness making it unlikely patient could successfully complete the study.
• Refusal of informed consent or of commitment to the full length of the study.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Eye Institute (NEI): collaborator

Study Sites (5)

University of Southern California, Doheny Eye Institute

Los Angeles, California, 90033, United States

Location

University of Miami, Bascom Palmer Eye Institute

Miami, Florida, United States

Location

Massachusettes Institute of Technology

Boston, Massachusetts, United States

Location

Oregon Health & Science University, Casey Eye Institute

Portland, Oregon, 97239, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Related Publications (25)

• Tan O, Li G, Lu AT, Varma R, Huang D; Advanced Imaging for Glaucoma Study Group. Mapping of macular substructures with optical coherence tomography for glaucoma diagnosis. Ophthalmology. 2008 Jun;115(6):949-56. doi: 10.1016/j.ophtha.2007.08.011. Epub 2007 Nov 5.

  PMID: 17981334 BACKGROUND

• Potsaid B, Baumann B, Huang D, Barry S, Cable AE, Schuman JS, Duker JS, Fujimoto JG. Ultrahigh speed 1050nm swept source/Fourier domain OCT retinal and anterior segment imaging at 100,000 to 400,000 axial scans per second. Opt Express. 2010 Sep 13;18(19):20029-48. doi: 10.1364/OE.18.020029.

  PMID: 20940894 BACKGROUND

• Grzywacz NM, de Juan J, Ferrone C, Giannini D, Huang D, Koch G, Russo V, Tan O, Bruni C. Statistics of optical coherence tomography data from human retina. IEEE Trans Med Imaging. 2010 Jun;29(6):1224-37. doi: 10.1109/TMI.2009.2038375. Epub 2010 Mar 18.

  PMID: 20304733 BACKGROUND

• Tan O, Chopra V, Lu AT, Schuman JS, Ishikawa H, Wollstein G, Varma R, Huang D. Detection of macular ganglion cell loss in glaucoma by Fourier-domain optical coherence tomography. Ophthalmology. 2009 Dec;116(12):2305-14.e1-2. doi: 10.1016/j.ophtha.2009.05.025. Epub 2009 Sep 10.

  PMID: 19744726 BACKGROUND

• Sung KR, Wollstein G, Schuman JS, Bilonick RA, Ishikawa H, Townsend KA, Kagemann L, Gabriele ML; Advanced Imaging in Glaucoma Study Group. Scan quality effect on glaucoma discrimination by glaucoma imaging devices. Br J Ophthalmol. 2009 Dec;93(12):1580-4. doi: 10.1136/bjo.2008.152223. Epub 2009 Aug 18.

  PMID: 19692363 BACKGROUND

• Wang Y, Lu A, Gil-Flamer J, Tan O, Izatt JA, Huang D. Measurement of total blood flow in the normal human retina using Doppler Fourier-domain optical coherence tomography. Br J Ophthalmol. 2009 May;93(5):634-7. doi: 10.1136/bjo.2008.150276. Epub 2009 Jan 23.

  PMID: 19168468 BACKGROUND

• Wang Y, Fawzi AA, Varma R, Sadun AA, Zhang X, Tan O, Izatt JA, Huang D. Pilot study of optical coherence tomography measurement of retinal blood flow in retinal and optic nerve diseases. Invest Ophthalmol Vis Sci. 2011 Feb 11;52(2):840-5. doi: 10.1167/iovs.10-5985. Print 2011 Feb.

  PMID: 21051715 BACKGROUND

• Zhao M, Izatt JA. Single-camera sequential-scan-based polarization-sensitive SDOCT for retinal imaging. Opt Lett. 2009 Jan 15;34(2):205-7. doi: 10.1364/ol.34.000205.

  PMID: 19148256 BACKGROUND

• Greenfield DS, Weinreb RN. Role of optic nerve imaging in glaucoma clinical practice and clinical trials. Am J Ophthalmol. 2008 Apr;145(4):598-603. doi: 10.1016/j.ajo.2007.12.018. Epub 2008 Mar 4.

  PMID: 18295183 BACKGROUND

• Mumcuoglu T, Townsend KA, Wollstein G, Ishikawa H, Bilonick RA, Sung KR, Kagemann L, Schuman JS Manuscript #AJO-08-106. Am J Ophthalmol Accepted for Publication: May 28, 2008.

  BACKGROUND

• Alasil T, Tan O, Lu AT, Huang D, Sadun AA. Correlation of Fourier domain optical coherence tomography retinal nerve fiber layer maps with visual fields in nonarteritic ischemic optic neuropathy. Ophthalmic Surg Lasers Imaging. 2008 Jul-Aug;39(4 Suppl):S71-9. doi: 10.3928/15428877-20080715-03.

  PMID: 18777877 BACKGROUND

• Asrani S, Sarunic M, Santiago C, Izatt J. Detailed visualization of the anterior segment using fourier-domain optical coherence tomography. Arch Ophthalmol. 2008 Jun;126(6):765-71. doi: 10.1001/archopht.126.6.765.

  PMID: 18541838 BACKGROUND

• Memarzadeh F, Tang M, Li Y, Chopra V, Francis BA, Huang D. Optical coherence tomography assessment of angle anatomy changes after cataract surgery. Am J Ophthalmol. 2007 Sep;144(3):464-5. doi: 10.1016/j.ajo.2007.04.009.

  PMID: 17765435 BACKGROUND

• Wang Y, Bower BA, Izatt JA, Tan O, Huang D. In vivo total retinal blood flow measurement by Fourier domain Doppler optical coherence tomography. J Biomed Opt. 2007 Jul-Aug;12(4):041215. doi: 10.1117/1.2772871.

  PMID: 17867804 BACKGROUND

• Sehi M, Ume S, Greenfield DS. Scanning laser polarimetry with enhanced corneal compensation and optical coherence tomography in normal and glaucomatous eyes. Invest Ophthalmol Vis Sci. 2007 May;48(5):2099-104. doi: 10.1167/iovs.06-1087.

  PMID: 17460267 BACKGROUND

• Pedersen CJ, Huang D, Shure MA, Rollins AM. Measurement of absolute flow velocity vector using dual-angle, delay-encoded Doppler optical coherence tomography. Opt Lett. 2007 Mar 1;32(5):506-8. doi: 10.1364/ol.32.000506.

  PMID: 17392903 BACKGROUND

• Memarzadeh F, Li Y, Chopra V, Varma R, Francis BA, Huang D. Anterior segment optical coherence tomography for imaging the anterior chamber after laser peripheral iridotomy. Am J Ophthalmol. 2007 May;143(5):877-9. doi: 10.1016/j.ajo.2006.11.055. Epub 2006 Dec 29.

  PMID: 17452177 BACKGROUND

• Sadda SR, Tan O, Walsh AC, Schuman JS, Varma R, Huang D. Automated detection of clinically significant macular edema by grid scanning optical coherence tomography. Ophthalmology. 2006 Jul;113(7):1187.e1-12. doi: 10.1016/j.ophtha.2005.12.020. Epub 2006 May 2.

  PMID: 16647123 BACKGROUND

• Huang XR, Knighton RW, Shestopalov V. Quantifying retinal nerve fiber layer thickness in whole-mounted retina. Exp Eye Res. 2006 Nov;83(5):1096-101. doi: 10.1016/j.exer.2006.05.020. Epub 2006 Jul 7.

  PMID: 16828473 BACKGROUND

• Sarunic MV, Applegate BE, Izatt JA. Real-time quadrature projection complex conjugate resolved Fourier domain optical coherence tomography. Opt Lett. 2006 Aug 15;31(16):2426-8. doi: 10.1364/ol.31.002426.

  PMID: 16880844 BACKGROUND

• Sehi M, Greenfield DS. Assessment of retinal nerve fiber layer using optical coherence tomography and scanning laser polarimetry in progressive glaucomatous optic neuropathy. Am J Ophthalmol. 2006 Dec;142(6):1056-9. doi: 10.1016/j.ajo.2006.07.043. Epub 2006 Sep 5.

  PMID: 17157591 BACKGROUND

• Huang XR, Knighton RW. Microtubules contribute to the birefringence of the retinal nerve fiber layer. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4588-93. doi: 10.1167/iovs.05-0532.

  PMID: 16303953 BACKGROUND

• Loewen NA, Zhang X, Tan O, Francis BA, Greenfield DS, Schuman JS, Varma R, Huang D; Advanced Imaging for Glaucoma Study Group. Combining measurements from three anatomical areas for glaucoma diagnosis using Fourier-domain optical coherence tomography. Br J Ophthalmol. 2015 Sep;99(9):1224-9. doi: 10.1136/bjophthalmol-2014-305907. Epub 2015 Mar 20.

  PMID: 25795917 DERIVED

• Sehi M, Goharian I, Konduru R, Tan O, Srinivas S, Sadda SR, Francis BA, Huang D, Greenfield DS. Retinal blood flow in glaucomatous eyes with single-hemifield damage. Ophthalmology. 2014 Mar;121(3):750-8. doi: 10.1016/j.ophtha.2013.10.022. Epub 2013 Nov 28.

  PMID: 24290800 DERIVED

• Sehi M, Zhang X, Greenfield DS, Chung Y, Wollstein G, Francis BA, Schuman JS, Varma R, Huang D; Advanced Imaging for Glaucoma Study Group. Retinal nerve fiber layer atrophy is associated with visual field loss over time in glaucoma suspect and glaucomatous eyes. Am J Ophthalmol. 2013 Jan;155(1):73-82.e1. doi: 10.1016/j.ajo.2012.07.005. Epub 2012 Oct 1.

  PMID: 23036570 DERIVED

Related Links

• AIGS main website

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• David Huang, MD, PhD

  Oregon Health and Science University

  STUDY CHAIR

• Joel S. Schuman, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Rohit Varma, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• David S. Greenfield, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• John Morrison, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• James Fujimoto, PhD

  Massachusettes Inistitute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David Huang, MD, PhD, Weeks Professor of Ophthalmic Research, Oregon Health & Science University

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: September 1, 2003
• Primary Completion: May 15, 2015
• Study Completion: May 15, 2015
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (5)