Advanced Imaging for Glaucoma Study (AIGS)
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Purpose
The specific aims of the clinical studies are to:
- 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.
- 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.
- 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 |
- 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 2013 |
| Estimated Primary Completion Date: | September 2013 (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 |
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).
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| Contact: Michelle Montalto | 503-494-1616 | montalto@ohsu.edu |
| United States, California | |
| University of Southern California, Doheny Eye Institute | Active, not recruiting |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| University of Miami, Bascom Palmer Eye Institute | Active, not recruiting |
| Miami, Florida, United States | |
| United States, Massachusetts | |
| Massachusettes Institute of Technology | Active, not recruiting |
| Boston, Massachusetts, United States | |
| United States, Oregon | |
| Oregon Health & Science University, Casey Eye Institute | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Janice Van Norman vannorma@ohsu.edu | |
| Contact: Michelle Montalto montalto@ohsu.edu | |
| United States, Pennsylvania | |
| University of Pittsburgh | Active, not recruiting |
| Pittsburgh, Pennsylvania, United States | |
| 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:
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: | May 16, 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 May 22, 2013