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The Collaborative Initial Glaucoma Treatment Study (CIGTS) is a prospective randomized study that compares initial surgery (trabeculectomy) to initial medical therapy in previously untreated early glaucoma eyes. This study was designed to re-evaluate the results that had been previously obtained by a similar study comparing trabeculectomy, laser trabeculoplasty, and medical therapy at Moorfields Eye Hospital.
The analysis of the CIGTS study by Jampel et al. (662). comprised intraoperative complications and early postoperative complications within the first month after surgery.
Among 300 patients that were randomized to the surgical arm, 465 trabeculectomies were performed. Most of the 165 additional operations were trabeculectomies in the second eye (non-study eye). 12% of eyes had intraoperative complications, anterior chamber bleeding (8%) and conjunctival button hole (1%) being the most frequent ones. Early postoperative complications were frequent (50%). However, serious or catastrophic complications were not observed. Shallow or flat anterior chamber, ptosis, serous choroidal detachment, and anterior chamber bleeding or hyphema had frequencies slightly over 10%. Three cases of localised suprachoroidal hemorrhages resolved spontaneously without resulting sequelae. Older patients were more likely to develop serous choroidal detachment, and blacks were more likely to develop ptosis.
The association of complications in the two eyes when both underwent trabeculectomy were significantly higher, particularly for ptosis (p < 0.0001), inflammation (p = 0.003), and serous choroidal detachment (p = 0.005). This may be due to elevated risk in the individual patient, but also related to the skill of the surgeon, or observer bias in the individual patients.
The spectrum of complications was similar to those occuring at surgery of eyes that had been treated before surgery in other studies. The percentages did not differ significantly even from those reported for the Advanced Glaucoma Intervention Study (AGIS).
There were no serious sight threatening complications. However, the proportion of eyes developing cataract could
not be assessed in the present report as it dealt only with the complications durung the first month. On the other hand, the interim clinical outcome reported over five years of CIGTS did not reveal differences of cataract formation between medically and surgically treated eyes.
Encapsulated blebs despite using antiproliferatives (mostly 5-FU) in 62% of cases were not infrequent (12%) considering the short follow-up of 1 months of the analysis.
In summary, CIGTS analysis of intra- and postoperative complications showed the usual risks without catastrophic complications in a large cohort of 465 trabeculectomies.