The Glaucoma Intensive Treatment Study (GITS), a randomized clinical trial: design, methodology and baseline data

Purpose The primary objective of the ongoing Glaucoma Intensive Treatment Study (GITS) is to evaluate the effectiveness of immediate intensive treatment in comparison with the commonly recommended stepped regimen on the predicted visual field. The two treatment arms are also being compared regarding quality of life (QoL), intraocular pressure (IOP) reduction, frequency of reported side-effects, adverse events and adherence to prescribed treatment. DesignParticipantsA randomized, two-centre, prospective open-labelled treatment trial for open-angle glaucoma. Individuals aged 40-78years with previously untreated and newly diagnosed glaucoma with early to moderate visual field loss were eligible. MethodsResultsPatients were randomized to initial treatment either using drug monotherapy in accordance with common glaucoma guidelines or using a more intensive approach including eyedrops containing drugs from three different classes combined with 360 degrees laser trabeculoplasty. The patients are to be followed for 5years at visits including standard automated perimetry, optical coherence tomography (OPT) and tonometry. Change of treatment is allowed and decided upon jointly with the patient as in conventional glaucoma management. Main outcome: The estimated predicted preserved visual field and QoL at end of expected lifetime. A total of 242 patients, 45% females, mean age 68years, were randomized. The median untreated IOP was 24mm Hg, and the median visual field index (VFI), indicating the percentage of a full field, was 92%. ConclusionGlaucoma Intensive Treatment Study is a clinical trial in which two groups of patients randomized to different initial intensities of IOP-reducing treatment are being compared with regard to rate of visual field progression and prediction of serious glaucomatous visual field loss at estimated at end of life.