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小梁切除术后2.0%环孢素滴眼液与0.1%倍他米松滴眼液的比较:一项随机临床试验。

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

作者信息

Babaei Esmaeil, Eslampoor Alireza, Daneshvar Ramin

机构信息

Department of Ophthalmology, Eye Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

Department of Ophthalmology, University of Florida, Gainesville, Florida, USA.

出版信息

Indian J Ophthalmol. 2025 Mar 1;73(Suppl 2):S272-S281. doi: 10.4103/IJO.IJO_345_24. Epub 2024 Oct 25.

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.

摘要

目的

与术后使用类固醇滴眼液相比,研究小梁切除术后使用2%环孢素A滴眼液对眼压(IOP)及手术成功率的影响。

研究设计

在机构环境中进行的前瞻性随机临床试验。

方法 患者:本研究纳入了40例原发性开角型青光眼且适合小梁切除术的患者。所有患者均接受了基于标准穹窿部的小梁切除术并联合丝裂霉素C。纳入的受试者该眼均无既往激光或眼内手术史。

干预措施

所有纳入的受试者被随机分配至术后使用2%环孢素A滴眼液组或0.1%倍他米松滴眼液组。

主要观察指标

通过压平眼压计测量眼压及手术成功率。

结果

在研究期间共观察了75例潜在符合条件的原发性开角型青光眼患者,其中40例符合研究标准并被随机分配至其中一个研究组。术后至少24个月,2%环孢素A组患者的眼压持续较低,青光眼药物使用较少,成功率较高(P < 0.0001)。环孢素组完全成功的情况更常见。此外,术后前3个月,环孢素A组的滤过泡更弥散、隆起,血管化程度更低(P≤0.01)。与此同时,环孢素组在前3个月干眼体征和症状较少(P < 0.03)。

结论

术后可使用2%环孢素A滴眼液替代类固醇滴眼液,其与手术成功率提高及干眼表现减少相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b166/12013290/8ad7fbe5154b/IJO-73-272-g002.jpg

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