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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145898
• Other study ID #: Cosopt and OAG progression
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: January 17, 2014
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• (Cosopt®, prostaglandin)
We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine, Department of Ophthalmology	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	3-year Change in OA PSV	Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity	Baseline and 36 month visits	No
Primary	3-year Change in OA EDV	Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity	Baseline and 36 month visits	No
Primary	3-year Change in OA RI	Measurement of change in ocular blood flow - ophthalmic artery resistance index	Baseline and 36 month visits	No
Primary	3-year Change in CRA PSV	Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity	Baseline and 36 month visits	No
Primary	3-year Change in CRA EDV	Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity	Baseline and 36 month visits	No
Primary	3-year Change in CRA RI	Measurement of change in ocular blood flow - central retinal arteries resistance index	Baseline and 36 month visits	No
Primary	3-year Change in OPP	Measurement of change in ocular perfusion pressure	Baseline and 36 month visits	No