Clinical trial NCT01677507: Glaucoma Biomarkers
Official title: Aqueous Humor Dynamic Components That Determine Intraocular Pressure Variance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Healthy
Keywords: glaucoma
aqueous humor dynamics
intraocular pressure
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: Mayo Clinic
name: National Eye Institute (NEI)
First posted: 2012-09-03
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Variation in Eye Pressure Between Individuals.
timeFrame: Measurement after 1 week of drug treatment
Secondary outcomes:
measure: Variation in Aqueous Flow Between Individuals.
timeFrame: 1 week after treatment
measure: Variation in Episcleral Venous Pressure.
timeFrame: 1 week treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Michigan
name: Sayoko E Moroi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kolli A, Toris CB, Reed DM, Gilbert J, Sit AJ, Gulati V, Kazemi A, Fan S, Musch DC, Moroi SE. The Effects of Topical Timolol and Latanoprost on Calculated Ocular Perfusion Pressure in Nonglaucomatous Volunteers. J Ocul Pharmacol Ther. 2021 Dec;37(10):565-574. doi: 10.1089/jop.2021.0068. Epub 2021 Oct 4.
citation: Man X, Costa R, Ayres BM, Moroi SE. Acetazolamide-Induced Bilateral Ciliochoroidal Effusion Syndrome in Plateau Iris Configuration. Am J Ophthalmol Case Rep. 2016 Oct;3:14-17. doi: 10.1016/j.ajoc.2016.05.003. Epub 2016 May 17.