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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: (Cosopt®, prostaglandin)

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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Glaucoma patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Alon Harris, PhD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 15, 2010
• First Submitted That Met QC Criteria: June 16, 2010
• First Posted (Estimate): June 17, 2010

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 17, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Glaucoma; progression; blood flow; Cosopt
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Timolol; Dorzolamide
• Other Study ID Numbers: Cosopt and OAG progression