Cutolo Carlo Alberto, Bagnis Alessandro, Scotto Riccardo, Bonzano Chiara, Traverso Carlo Enrico
Clinica Oculistica Università di Genova DiNOGMI - Ospedale Policlinico San Martino, Viale Benedetto XV, 5, 16136, Genoa, Italy.
Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):181-186. doi: 10.1007/s00417-017-3844-1. Epub 2017 Nov 17.
Our purpose was to evaluate the clinical safety and efficacy of CO laser-assisted sclerectomy surgery (CLASS) with Mitomycin C (MMC) in open angle glaucoma (OAG).
This was a prospective, uncontrolled, interventional case series. All subjects underwent CLASS procedure by a single surgeon. After the dissection of a partial thickness scleral flap, topical MMC 0.2 mg/ml was applied to the sclera and the conjunctiva for 3 min. The CO laser with a beam-manipulating system was used to ablate the scleral tissue and expose the Schlemm's canal area. Primary outcomes: intraocular pressure (IOP) change, number of IOP-lowering medicaments change. Adverse events were evaluated as secondary outcomes.
Twenty-one eyes of 21 patients underwent the CLASS procedure. Thirteen were primary OAG (62%), two normal pressure glaucoma (10%), three exfoliative glaucoma (14%) and three others secondary OAG. With a mean (SD) follow-up of 15.3 (5.9) months, the IOP changed from 25.4 (6.7) mmHg at baseline to 10.9 (3.4) mmHg al the last visit. Mean reduction of IOP was -14.5 mmHg (95% CI, -17.7 to -11.2, P < 0.001). The median (IQR) number of IOP-lowering medication decreased from 3 (3-3) at baseline to 1 (0-1) at the last visit (P < 0.001). Visual acuity did not change significantly. Adverse events: five eyes (24%) developed iris adhesion to the filtration area that was successfully managed with office-based procedures. In one case (5%), CLASS was converted to trabeculectomy due to intraoperative perforation of the ablated area. There was one case of hypotony maculopathy successfully treated with placement of additional transconjunctival scleral flap sutures.
The CLASS procedure with MMC is clinically safe and effective maintaining a large reduction in IOP and in the number of IOP-lowering medications with a mean follow-up of 15 months. Iris adhesion at the filtrating area warrants further evaluation and possibly reflects the surgeon's learning curve.
我们的目的是评估在开角型青光眼（OAG）中使用丝裂霉素C（MMC）的CO激光辅助巩膜切除术（CLASS）的临床安全性和有效性。
这是一个前瞻性、非对照、干预性病例系列。所有受试者均由同一位外科医生进行CLASS手术。在切开部分厚度的巩膜瓣后，将0.2mg/ml的局部MMC应用于巩膜和结膜3分钟。使用带有光束操纵系统的CO激光消融巩膜组织并暴露施莱姆管区域。主要结局：眼压（IOP）变化、降低眼压药物数量的变化。不良事件作为次要结局进行评估。
21例患者的21只眼接受了CLASS手术。其中13只为原发性开角型青光眼（62%），2例为正常眼压性青光眼（10%），3例为剥脱性青光眼（14%），3例为其他继发性开角型青光眼。平均（标准差）随访15.3（5.9）个月，眼压从基线时的25.4（6.7）mmHg降至最后一次随访时的10.9（3.4）mmHg。眼压平均降低-14.5mmHg（95%CI，-17.7至-11.2，P<0.001）。降低眼压药物的中位数（四分位间距）从基线时的3（3-3）降至最后一次随访时的1（0-1）（P<0.001）。视力无明显变化。不良事件：5只眼（24%）出现虹膜与滤过区域粘连，通过门诊手术成功处理。1例（5%）因术中消融区域穿孔，CLASS手术转为小梁切除术。有1例低眼压性黄斑病变通过额外放置经结膜巩膜瓣缝线成功治疗。
使用MMC的CLASS手术在临床中是安全有效的，平均随访15个月时眼压和降低眼压药物数量大幅降低。滤过区域的虹膜粘连值得进一步评估，可能反映了外科医生的学习曲线。
