Advanced Imaging for Glaucoma Study (NCT01314326) | Clinical Trial Compass
CompletedNot Applicable
Advanced Imaging for Glaucoma Study
United States832 participantsStarted 2003-09
Plain-language summary
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.
Who can participate
Age range40 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Developing glaucoma or progression with glaucoma as defined by study criteria