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Completed

NCT Number: NCT01145898

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.

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Key information

Conditions

Glaucoma Disease Attributes Disease Progression Eye Diseases Ocular Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University School of Medicine, Department of Ophthalmology

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

(Cosopt®, prostaglandin)

Drug

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.

Primary outcomes

  1. 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)

    Time frame: Baseline and 6 month visits

    Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

  2. 6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)

    Time frame: Baseline and 6 month visits

    Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity

  3. 6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)

    Time frame: 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.

  4. 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)

    Time frame: Baseline and 6 month visits

    Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity

  5. 6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)

    Time frame: Baseline and 6 month visits

    Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity

  6. 6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)

    Time frame: 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.

  7. 6-month Change in Ocular Perfusion Pressures (OPP)

    Time frame: 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.

  8. 3-year Change in OA PSV

    Time frame: Baseline and 36 month visits

    Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity

  9. 3-year Change in OA EDV

    Time frame: Baseline and 36 month visits

    Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity

  10. 3-year Change in OA RI

    Time frame: Baseline and 36 month visits

    Measurement of change in ocular blood flow - ophthalmic artery resistance index

  11. 3-year Change in CRA PSV

    Time frame: Baseline and 36 month visits

    Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity

  12. 3-year Change in CRA EDV

    Time frame: Baseline and 36 month visits

    Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity

  13. 3-year Change in CRA RI

    Time frame: Baseline and 36 month visits

    Measurement of change in ocular blood flow - central retinal arteries resistance index

  14. 3-year Change in OPP

    Time frame: Baseline and 36 month visits

    Measurement of change in ocular perfusion pressure

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2010
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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