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

Completed

• Conditions: Glaucoma
• Interventions: Drug: (Cosopt®, prostaglandin)

• Registration Number: NCT01145898
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Primary Completion: 2012-01
• Study Completion: 2012-10
• Results First Submitted: 2013-09-20
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-17
• Last Update Submitted: 2014-01-17
• Results First Posted: 2014-01-22
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glaucoma patients	(Cosopt®, prostaglandin)	Patients with Glaucoma

Primary Outcome Measures

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

Trial Locations

Locations (1)

Indiana University School of Medicine, Department of Ophthalmology; 🇺🇸 Indianapolis, Indiana, United States