Quaranta Luciano, Biagioli Elena, Galli Francesca, Poli Davide, Rulli Eliana, Riva Ivano, Hollander Lital, Katsanos Andreas, Longo Antonio, Uva Maurizio G, Torri Valter, Weinreb Robert N
Department of Medical and Surgical Specialties Section of Ophthalmology, University of Brescia, Brescia, Italy.
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Adv Ther. 2016 Aug;33(8):1305-15. doi: 10.1007/s12325-016-0358-x. Epub 2016 Jun 16.
To investigate the efficacy of a treatment strategy with latanoprost and dorzolamide in primary pediatric glaucoma patients partially responsive to surgery.
Single arm, prospective, interventional multicenter study. Primary pediatric glaucoma patients younger than 13 years after a single surgical procedure with IOP between 22 and 26 mmHg were considered eligible. At baseline, patients were allocated to latanoprost monotherapy once daily. Depending on intraocular pressure (IOP) reduction at first visit, the patients were allocated to one of three groups: continuation of latanoprost monotherapy, addition of dorzolamide twice daily, or switch to dorzolamide three times daily. The same approach for allocation in medication groups was used in all subsequent visits. Patients in the dorzolamide monotherapy group with IOP reduction <20% from baseline were considered non-responders and withdrawn. Study treatment and patient follow-up will continue for 3 years or until treatment failure. The primary endpoint is the percentage of responders. Secondary endpoints are time to treatment failure and frequency of adverse events.
A total of 37 patients (69 eyes) were enrolled. The mean age was 4.0 ± 3.8 years, the female/male ratio was 1/1.7, and the majority of patients were Caucasian. Eighty percent of patients had bilateral glaucoma. Goniotomy was the most frequently performed surgery (38.6%), followed by trabeculotomy (22.8%), trabeculectomy (21.1%), and trabeculectomy plus trabeculotomy (17.5%). The baseline IOP was 23.6 ± 1.5 mmHg.
The study population is representative of patients frequently encountered after the first surgery for primary pediatric glaucoma. The study will produce evidence on the medium-term efficacy of a defined pharmacological approach.
探讨拉坦前列素和多佐胺联合治疗策略对部分手术治疗有效的原发性儿童青光眼患者的疗效。
单臂、前瞻性、介入性多中心研究。纳入年龄小于13岁、单次手术后眼压在22至26 mmHg之间的原发性儿童青光眼患者。基线时，患者被分配接受每日一次的拉坦前列素单药治疗。根据首次就诊时眼压降低情况，患者被分为三组之一：继续拉坦前列素单药治疗、加用每日两次的多佐胺或改为每日三次的多佐胺治疗。在所有后续就诊中，药物分组采用相同方法。多佐胺单药治疗组中眼压较基线降低<20%的患者被视为无反应者并退出研究。研究治疗和患者随访将持续3年或直至治疗失败。主要终点是有反应者的百分比。次要终点是治疗失败时间和不良事件发生率。
共纳入37例患者（69只眼）。平均年龄为4.0±3.8岁，女性/男性比例为1/1.7，大多数患者为白种人。80%的患者患有双侧青光眼。房角切开术是最常施行的手术（38.6%），其次是小梁切开术（22.8%）、小梁切除术（21.1%）和小梁切除术加小梁切开术（17.5%）。基线眼压为23.6±1.5 mmHg。
该研究人群代表了原发性儿童青光眼首次手术后常见的患者类型。该研究将为一种明确的药物治疗方法的中期疗效提供证据。
