Comparison of postoperative cyclosporine 2.0% versus betamethasone 0.1% eye drops following trabeculectomy: A randomized clinical trial

Abstract

Purpose: To investigate the effect of cyclosporine A 2% eye drop following trabeculectomy on intraocular pressure (IOP) and surgical success compared to postoperative steroid drop.

Study design: Prospective, randomized clinical trial in an institutional setting.

Methods patients: Forty patients with primary open-angle glaucoma and candidates for trabeculectomy were included in this study. Standard fornix-based trabeculectomy augmented with mitomycin C was performed for all patients. None of the included subjects had a history of prior laser or intraocular surgery in that eye.

Intervention: All included subjects were randomly assigned to either postoperative cyclosporine A 2% or betamethasone 0.1% eye drops.

Main outcome measures: IOP measured by applanation tonometer and surgical success rate.

Results: Seventy-five potentially eligible POAG patients were seen during the study period, and 40 met the study criteria and were randomly assigned to one of the study groups. Patients in the cyclosporine A 2% group had consistently lower IOP, fewer glaucoma medications, and higher success rates for at least 24 months after surgery ( P < 0.0001). Complete success was more frequent in the cyclosporine group. Moreover, the cyclosporine A group had more diffuse and elevated bleb with less vascularity in the first 3 months after surgery ( P ≤ 0.01). This was paralleled with fewer dry eye signs and symptoms in the cyclosporine group in the first 3 months ( P < 0.03).

Conclusion: Postoperative cyclosporine A 2% eye drop can be used instead of steroid drops and is associated with improved surgical success and decreased dry eye manifestations.

Figure 1

Profile of the clinical trial recruitment and participation

Figure 2

Intraocular pressure (IOP) in the cyclosporine A 2% and betamethasone groups after trabeculectomy. Preop, preoperative; POW, postoperative week; POM, postoperative month

Figure 3

The number of glaucoma medications in the cyclosporine A 2% and betamethasone groups after trabeculectomy. Preop, preoperative; POW, postoperative week; POM, postoperative month

Figure 4

Bleb morphology in the cyclosporine A 2% and betamethasone groups, 1 and 3 months after trabeculectomy. Bonferroni’s adjusted level of significance is P < 0.0085. H0, flat bleb; H1, low bleb; H2, medium bleb; H3, high bleb; E0, <1 clock hour; E1, 1-2 clock hours; E2, 2-4 clock hours; E3, >4 clock hours; V0, avascular white bleb; V1, avascular cystic bleb; V2, mild vascularity; V3, moderate vascularity; V4, severe vascularity

Figure 5

Dry eye manifestations morphology in the cyclosporine A 2% and betamethasone groups in the first 6 months after trabeculectomy. Bonferroni’s adjusted level of significance is P < 0.0042. Conj., conjunctival; FBS, foreign body sensation; PEE, punctate epithelial erosions

Figure 6

Surgical success rate according to different criteria in the cyclosporine A 2% and betamethasone groups after trabeculectomy. POM, postoperative month

Figure 7

Survival probability of complete surgical success according to different criteria in the cyclosporine A 2% and betamethasone groups after trabeculectomy. POM, postoperative month