Advanced Imaging for Glaucoma Study (AIGS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01314326
First received: March 11, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The specific aims of the clinical studies are to:

  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. 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. Determine the sensitivity and specificity of glaucoma diagnosis based on advanced imaging tests.

Condition
Glaucoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Advanced Imaging for Glaucoma Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Developing glaucoma or progression with glaucoma as defined by study criteria [ Time Frame: 5 years or the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2003
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

Inclusion Criteria for Normal Participants:

  • 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.

Inclusion Criteria for Glaucoma Suspects & Pre-Perimetric Glaucoma Participants:

  • 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.

Inclusion Criteria for Perimetric Glaucoma Participants:

  • Abnormal VF and
  • Glaucomatous ONH of NFL defect.

Exclusion Criteria Common to All Groups:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314326

Locations
United States, California
University of Southern California, Doheny Eye Institute
Los Angeles, California, United States, 90033
United States, Florida
University of Miami, Bascom Palmer Eye Institute
Miami, Florida, United States
United States, Massachusetts
Massachusettes Institute of Technology
Boston, Massachusetts, United States
United States, Oregon
Oregon Health & Science University, Casey Eye Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Study Chair: David Huang, MD, PhD Oregon Health and Science University
Principal Investigator: 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
  More Information

Additional Information:
Publications:
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;52(2):840-5.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Huang, David Huang, MD, PhD, Weeks Professor of Ophthalmic Research, Oregon Health & Science University, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01314326     History of Changes
Other Study ID Numbers: OHSU IRB #00006611 - AIGS, R01EY013516
Study First Received: March 11, 2011
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Optical Coherence Tomography
Glaucoma
Advanced Imaging

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014