Awardee OrganizationMASSACHUSETTS EYE AND EAR INFIRMARY
Description
Abstract Text
This proposal is a plan for carrying out a multicenter randomized clinical
trial designed to assess the efficacy of argon laser trabeculoplasty (ALT)
as an alternative to standard medical therapy of open angle glaucoma. The
trial will involve the recruitment of 240 patients with newly diagnosed
symmetrical open angle glaucoma. Only patients aged 30 or older (of either
sex) with intraocular pressures of 27 mm. Hg. or greater, and evidence of
optic nerve damage in both eyes will be eligible for enrollment. The
patients will each be followed for a minimum of two years in order to
collect information on pressure levels over the course of the trial and to
provide comparative data on the rate of vision field loss and increased
optic nerve cupping. Treatment groups will be compared at the end of the
two years with regard to the amount of medical treatment needed to control
the intraocular pressure and/or control glaucomatous nerve damage. The eye
to be lasered will be randomly selected. The ALT will consist of 96 burns
delivered onto the anterior middle aspect of the trabecular meshwork,
avoiding the posterior or uveal meshwork. The burns will be delivered at a
suitable intensity of cause blanching of the meshwork just at the threshold
of bubble formation (between 700 and 1200 MW per lesion). The fellow eye
assigned to medical therapy will be placed on a single topical medication.
Eyes requiring added treatment over and above the initial treatment (i.e.,
laser trabeculoplasty or single topical medication) will have subsequent
topical medication(s) added in a step fashion according to a protocol. The
trial will involve a total of 6 Clinical Centers, a Data Coordinating
Center, a Disc Stereo Photo Reading Center, and a Visual Field Reading
Center.
No Sub Projects information available for 5U01EY004582-06
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