US EPA

3236831 

Journal Article 

Collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery 

Lichter, PR; Musch, DC; Gillespie, BW; Guire, KE; Janz, NK; Wren, PA; Mils, RP; CIGTS Study Grp 

2001 

1 

Ophthalmology
ISSN: 0161-6420
EISSN: 1549-4713 

108 

11 

1943-1953 

WOS:000171964500020 

Purpose: To report interim outcome data, using all
available follow-up through 5 years after treatment initiation, in the Collaborative Initial
Glaucoma Treatment Study (CIGTS). Design: Randomized clinical trial. Participants. Six hundred
seven newly diagnosed glaucoma patients. Methods: In a randomized clinical trial, 607 patients
with newly diagnosed open-angle glaucoma were initially treated with either medication or
trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up,
patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone
interviews were conducted at similar frequency to the clinical visits. Patients in both arms of
CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at
or below a predetermined target pressure specific for each individual eye. Visual field (VF)
scores were analyzed by time-specific comparisons and by repeated measures models. Main Outcome
Measures: VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity
(VA), IOP, and cataract were also studied. Results: On the basis of completed follow-up through 4
years and partially completed through 5 years, VF loss did not differ significantly by initial
treatment. Over the entire period of follow-up, surgical patients had a greater risk of
substantial VA loss compared with medical patients. However, by 4 years after treatment, the
average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine
group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The
rate of cataract requiring removal was greater in the surgically treated group. Conclusions: Both
initial medical or initial surgical therapy result in about the same VF outcome after up to 5
years of follow-up. VA loss was greater in the surgery group, but the differences between groups
seem to be converging as follow-up continues. When aggressive treatment aimed at substantial
reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because
4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions,
these interim CIGTS outcomes do not support altering current treatment approaches to open-angle
glaucoma. Ophthalmology 2001;108:1943-1953 (C) 2001 by the American Academy of Ophthalmology.