Glaucoma Biomarkers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Ocular |
| Therapuetic Areas: | Ophthalmology, Other |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 5/19/2016 |
| Start Date: | August 2012 |
| End Date: | December 2016 |
Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
Glaucoma is a major cause of blindness. The inability to predict a patient's IOP response to
medications is a critical barrier for the clinician to consistently provide highly effective
IOP-based treatments. Current trial-and error approaches to glaucoma management are
inefficient and have not addressed this barrier as there are no predictive factors for drug
response. Our long-term goal is to improve outcomes by identifying biomarkers and
environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of
disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of
this research project is to address this critical barrier by focusing on physiological
factors that predict IOP response to drugs.
medications is a critical barrier for the clinician to consistently provide highly effective
IOP-based treatments. Current trial-and error approaches to glaucoma management are
inefficient and have not addressed this barrier as there are no predictive factors for drug
response. Our long-term goal is to improve outcomes by identifying biomarkers and
environmental factors that profile a patient at risk for glaucoma by age-of-onset, rate of
disease progression, "poor response" to treatment, and large IOP fluctuation. Our purpose of
this research project is to address this critical barrier by focusing on physiological
factors that predict IOP response to drugs.
Inclusion Criteria:
- Either gender.
- Any self-declared ethnoracial category.
- Greater than or equal to 40 years.
- Healthy eyes with the crystalline lens, without glaucoma (cup:disc ratio < 0.8 both
eyes; asymmetry of cup:disc ratio between eyes < 0.2).
- Open angles.
- Ability to cooperate for aqueous humor dynamic studies.
- Nonprescription and prescription topical ophthalmic products and systemic medications
other than those mentioned in the exclusion criteria will be allowed during the
study.
- Contact lenses removed prior to topical fluorescein instillation, and not used until
the end of each fluorophotometry session.
- Able to participate on site over the multi-visit study period.
Exclusion Criteria:
- Women who are pregnant due to IOP changes.
- Any form of glaucoma, including extremely narrow angle with complete or partial
closure.
- Current use of any glaucoma medication, either topically or orally.
- Chronic or recurrent inflammatory eye disease.
- Ocular trauma within the past 6 months.
- Ocular infection or ocular inflammation in the past 3 months.
- Clinically significant retinal disease.
- Any abnormality preventing reliable fluorophotometry of either eye, such as corneal
scarring or severe dry eye that results in punctate fluorescein staining of the
cornea.
- Intraocular surgery within 6 months.
- Serious hypersensitivity to any components of the study medications or risk from
treatment with glaucoma medications, such as severe asthma or emphysema.
- Subjects must be on a stable regimen for at least 30 days prior to the Visit 1
regarding a chronic systemic medication that may affect IOP (i.e., sympathomimetic
agents, beta-blockers, alpha-adrenergic agonists, alpha-adrenergic blockers, calcium
channel blockers, angiotensin converting enzyme inhibitors, etc.). Any change of such
medication during the study period will result in exclusion.
- Use of any glucocorticoid by any route. Subject must be washed out of the
glucocorticoid for at least 2 weeks before study entry.
We found this trial at
3
sites
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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