Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection

Mashhad University of Medical Sciences

Status: Completed

Conditions: Intraocular Pressure Change in Intravitreal Injection

Treatments: Drug: Mannitol; Drug: Brimonidine; Drug: Timolol; Drug: Acetazolamide; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02140450

910292

Details and patient eligibility

About

To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.

Full description

Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.

Enrollment: 70 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all patients who candidate for receiving intravitreal bevacizumab

Exclusion criteria

• patients who had advanced glaucoma
• patients who received antiglaucoma agents in the past
• patients who had corneal scar which affect IOP measurement

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 5 patient groups

Timolol

Active Comparator group

Description:

Timolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection

Treatment:

Drug: Timolol

Brimonidine

Active Comparator group

Description:

Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection

Treatment:

Drug: Brimonidine

Acetazolamide

Active Comparator group

Description:

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

Treatment:

Drug: Acetazolamide

Mannitol

Active Comparator group

Description:

Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection

Treatment:

Drug: Mannitol

Placebo

Sham Comparator group

Description:

Artificial tears, 2 drops, 1-2 hours before intravitreal injection

Treatment:

Drug: Placebo