Kalala A, Gillmann K, Mermoud A
Centre promotion santé communautaire, Kinshasa, RDC Congo.
Glaucoma Research Center, Montchoisi Clinic, Swiss Visio Network, Lausanne, Switzerland.
J Fr Ophtalmol. 2020 Mar;43(3):228-236. doi: 10.1016/j.jfo.2019.07.024. Epub 2020 Jan 24.
Two of the hurdles that are facing ophthalmologists in developing countries are scarcity of resources and patient follow-up. Deep sclerectomy (DS) has proven less costly and more effective than topical therapies and has a more favorable safety profile than trabeculectomy. The main factors preventing its use in developing countries are the need to perform laser goniopuncture in 40-80% of cases to maintain filtration and the risk of postoperative iris incarceration. The purpose of this study is to assess the efficacy and safety profile in advanced open-angle glaucoma of a relatively new surgical technique designed to overcome this limitation: penetrating DS.
This was an investigator-initiated, prospective, interventional study, conducted at a single ophthalmology center in Kinshasa, Congo. The study was conducted in full compliance with the Declaration of Helsinki.
Fifty-one eyes (34 patients) with uncontrolled advanced primary open-angle glaucoma (visual field mean deviation<-10 dBs) were enrolled between October 2012 and June 2016. Age, gender, comorbidities (hypertension/diabetes), best-corrected visual acuity, topical medications, medicated and unmedicated intraocular pressure (IOP) were recorded. All patients underwent penetrating DS, during which, following standard dissection of the scleral flaps, the anterior chamber was penetrated through the trabeculo-Descemet membrane and an iridectomy was performed. Patients attended postoperative appointments at months 1, 3, 6 and 12. Surgical success was defined as a 20% reduction of IOP from baseline in conjunction with a 12-month unmedicated IOP≤12mmHg.
The mean age was 64.5±14.0 years (44.1% female, 100% African). Mean IOP decreased from 20.2±6.1 (medicated) and 30.7±9.8mmHg (unmedicated) preoperatively to 12.1±4.1 at 12 months. Concomitantly, the number of topical medications decreased from 1.5±0.7 to 0.0. Complete surgical success was achieved in 64.7%. Four eyes (7.8%) were considered surgical failures due to uncontrolled IOP. None of the eyes lost light perception or required additional surgery. A significant association between surgical failure and hypertension was observed (HR=1.49; P=0.008). There were no intraoperative complications. Postoperatively, 4 bleb encapsulations (7.8%) and 1 iris incarceration (2%) were observed.
The present study demonstrates that penetrating DS achieved similar efficacy and safety results to traditional non-penetrating DS. In addition, it showed a lower potential for intraoperative complications, which might be associated with a more benign surgical learning curve. Finally, the rates of serious postoperative complications (iris incarceration, choroidal effusion and hypotony) were significantly lower than in DS and trabeculectomy, and this technique does not require subsequent Nd: YAG laser goniopuncture to maintain filtration, making frequent follow-up visits less critical. In view of these findings, perforating deep sclerectomy could offer a viable option for glaucoma management in developing countries as well as worldwide.
发展中国家的眼科医生面临两个障碍,即资源稀缺和患者随访问题。深层巩膜切除术(DS)已被证明比局部治疗成本更低且更有效,并且与小梁切除术相比具有更良好的安全性。阻碍其在发展中国家应用的主要因素是在40%-80%的病例中需要进行激光房角穿刺以维持滤过,以及术后虹膜嵌顿的风险。本研究的目的是评估一种旨在克服这一局限性的相对较新的手术技术——穿透性DS在晚期开角型青光眼中的疗效和安全性。
这是一项由研究者发起的前瞻性干预性研究,在刚果金沙萨的一个眼科中心进行。该研究完全符合《赫尔辛基宣言》。
2012年10月至2016年6月期间纳入了51只眼(34例患者)患有未控制的晚期原发性开角型青光眼(视野平均偏差<-10dBs)。记录年龄、性别、合并症(高血压/糖尿病)、最佳矫正视力、局部用药、用药和未用药时的眼压(IOP)。所有患者均接受穿透性DS,在此过程中,在对巩膜瓣进行标准解剖后,通过小梁-Descemet膜穿透前房并进行虹膜切除术。患者在术后1、3、6和12个月进行随访。手术成功定义为眼压从基线降低20%,且12个月未用药时眼压≤12mmHg。
平均年龄为64.5±14.0岁(女性占44.1%,均为非洲人)。平均眼压从术前用药时的20.2±6.1mmHg和未用药时的30.7±9.8mmHg降至12个月时的12.1±4.1mmHg。同时,局部用药的数量从1.5±0.7降至0.0。64.7%的患者实现了完全手术成功。4只眼(7.8%)因眼压未得到控制被视为手术失败。没有眼睛失去光感或需要额外手术。观察到手术失败与高血压之间存在显著关联(HR=1.49;P=0.008)。术中无并发症。术后,观察到4例滤过泡包裹(7.8%)和1例虹膜嵌顿(2%)。
本研究表明,穿透性DS取得了与传统非穿透性DS相似的疗效和安全性结果。此外,它显示出术中并发症的可能性较低,这可能与更良性的手术学习曲线有关。最后,严重术后并发症(虹膜嵌顿、脉络膜渗漏和低眼压)的发生率显著低于DS和小梁切除术,并且该技术不需要后续的Nd:YAG激光房角穿刺来维持滤过,使得频繁的随访不那么关键。鉴于这些发现,穿透性深层巩膜切除术可为发展中国家以及全球范围内的青光眼治疗提供一个可行的选择。