Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: (Cosopt®, prostaglandin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 30 years or older. Diagnosis: confirmed open-angle glaucoma in at least one eye: glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry glaucomatous optic disc cupping agreement between two baseline exams for reliability Best corrected visual acuity at least 20/60 in at least one eye. Prior Humphrey visual fields demonstrate acceptable reliability standards. Exclusion Criteria: Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields. Evidence of exfoliation or pigment dispersion. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis). History or signs of intraocular trauma. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment. Any abnormality preventing reliable applanation tonometry. Current use of any ophthalmic or systemic steroid which may interfere with this investigation. Cataract surgery within the past year. Resting pulse < 50 beats per minute. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma patients<br>Patients with Glaucoma | Drug: (Cosopt®, prostaglandin)<br>* We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.<br>* Other names: Cosopt is a trade name drug which is a combination of dorzolamide and timolol.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) | Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity | Baseline and 6 month visits | 
| 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV) | Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity | Baseline and 6 month visits | 
| 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI) | Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel. | Baseline and 6 month visits | 
| 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV) | Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity | Baseline and 6 month visits | 
| 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV) | Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity | Baseline and 6 month visits | 
| 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI) | Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel. | Baseline and 6 month visits | 
| 6-month Change in Ocular Perfusion Pressures (OPP) | Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye. | Baseline and 6 month visits | 
| 3-year Change in OA PSV | Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity | Baseline and 36 month visits | 
| 3-year Change in OA EDV | Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity | Baseline and 36 month visits | 
| 3-year Change in OA RI | Measurement of change in ocular blood flow - ophthalmic artery resistance index | Baseline and 36 month visits | 
| 3-year Change in CRA PSV | Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity | Baseline and 36 month visits | 
| 3-year Change in CRA EDV | Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity | Baseline and 36 month visits | 
| 3-year Change in CRA RI | Measurement of change in ocular blood flow - central retinal arteries resistance index | Baseline and 36 month visits | 
| 3-year Change in OPP | Measurement of change in ocular perfusion pressure | Baseline and 36 month visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Cosopt, blood flow, progression