Clinical trial NCT01145898: Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
Official title: Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Cosopt
blood flow
progression
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients

Brief summary: To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

Detailed description: To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.

Eligibility criteria: Inclusion Criteria:

1. Age: 30 years or older.
2. Diagnosis: confirmed open-angle glaucoma in at least one eye:

   1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
   2. glaucomatous optic disc cupping
   3. agreement between two baseline exams for reliability
3. Best corrected visual acuity at least 20/60 in at least one eye.
4. Prior Humphrey visual fields demonstrate acceptable reliability standards.

Exclusion Criteria:

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields.
2. Evidence of exfoliation or pigment dispersion.
3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
5. History or signs of intraocular trauma.
6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
7. Any abnormality preventing reliable applanation tonometry.
8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
9. Cataract surgery within the past year.
10. Resting pulse \< 50 beats per minute.
11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Primary outcomes:
measure: 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
timeFrame: Baseline and 6 month visits
measure: 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)
timeFrame: Baseline and 6 month visits
measure: 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)
timeFrame: Baseline and 6 month visits
measure: 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
timeFrame: Baseline and 6 month visits
measure: 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
timeFrame: Baseline and 6 month visits
measure: 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
timeFrame: Baseline and 6 month visits
measure: 6-month Change in Ocular Perfusion Pressures (OPP)
timeFrame: Baseline and 6 month visits
measure: 3-year Change in OA PSV
timeFrame: Baseline and 36 month visits
measure: 3-year Change in OA EDV
timeFrame: Baseline and 36 month visits
measure: 3-year Change in OA RI
timeFrame: Baseline and 36 month visits
measure: 3-year Change in CRA PSV
timeFrame: Baseline and 36 month visits
measure: 3-year Change in CRA EDV
timeFrame: Baseline and 36 month visits
measure: 3-year Change in CRA RI
timeFrame: Baseline and 36 month visits
measure: 3-year Change in OPP
timeFrame: Baseline and 36 month visits
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, Department of Ophthalmology
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Alon Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References: