Background Corneal blindness is associated with the change of corneal structure, and conventional keratoplasty cannot regain vision in these eyes.Keratoprosthesis is well used for patients unsuitable for standard keratoplasty.Boston type Ⅰ keratoprosthesis is one of the most commonly employed in the world,but it has not been well used in China.Objective This study was to evaluate the long-term outcome and safety of Boston type Ⅰ keratoprosthesis in China.Methods A pilot study was carried out for a descriptive prospective clinical trial under the approval of Ethic Committee of Henan Provincial People's Hospital and Henan Eye Institute.Sixteen eyes of 15 patients with severe corneal blindness which were not suitable for usual management were recruited, with the gender being males and ages of (50.4± 13.0) years.The causes of blindness included thermal and chemical injury in 8 eyes of 7 patients,herpes simplex keratitis in 3 eyes of 3 patients,Stevens-Johnson syndrome in 1 eye of 1 patient,mechanical trauma in 2 eyes of 2 patients and infectious keratitis in 2 eyes of 2 patients.Fourteen of the 16 eyes received therapeutic keratoplasty once or more before, and 7 eyes had glaucoma history,pseudophakia was in 5 eyes and aphakia was in 4 eyes.The best corrected visual acuity (BCVA) is 0.05 in 1 eye,finger counting in 7 eyes and hand motion in 8 eyes.Implantation of Boston type Ⅰ keratoprosthesis was performed on the 16 eyes and followed-up for (47.5 ±23.8) months (ranged from 19 throughout 84 months) after obtaining of written informed consent from each patient.The postoperative BCVA,postoperative complication and eye numbers of keratoprosthesis in site were recorded.Results The surgeries of Boston type Ⅰ keratoprosthesis or combination procedures,such as lens or intraocular lens (IOL) extraction,iridectomy,cyclitic membrane removal and vitrectomy were successful in all the eyes.One month after surgery,the postoperative BCVA was obviously improved in 14 eyes, with the BCVA ≥ 1.0 in 3 eyes,0.5 ≤ BCVA＜ 1.0 in 4 eyes and O.1 ≤ BCVA＜0.5 in 7 eyes, the vision was unchanged in 2 eyes due to end-stage glaucoma before operation.BCVA remained ≥ 0.1 in 9 eyes at the end of following-up duration.Postoperative complications included retromembrane proliferation in 7 eyes,corneal melting in 6 eyes and glaucoma in 4 eyes.Severe postoperative complications were fungal keratitis,endophthalmitis and device extrusion respectively and keratoprosthesis prolapse,so penetrating keratoplasty was carried out to replace the keratoprosthesis.Implanted Boston type Ⅰ keratoprosthesis was in site in 13 eyes at the end of following-up.Conclusions The Boston type Ⅰ keratoprosthesis might be a viable method to provide visual recovery for the eyes with severe corneal blindness unsuitable for standard keratoplasty.It is mandatory for long-term follow-up and prevention and management of postoperative complications.%背景 角膜盲的原因主要是严重的角膜组织结构的破坏,常规的角膜移植术常无法达到复明的目的.人工角膜移植术适用于常规角膜移植术无法治疗的严重角膜盲,目前全球使用最为广泛的人工角膜是波士顿Ⅰ型人工角膜,但其在中国的临床应用尚少,其在中国患者中的临床应用疗效、并发症及其处理的报道少见.目的 研究波士顿Ⅰ型人工角膜用于中国严重角膜盲患者后的长期疗效和安全性.方法 采用前瞻性系列描述性病例观察研究,纳入2008年8月至2015年8月于河南省眼科研究所、山西省眼科医院就诊的不适合行常规角膜移植术的严重角膜盲患者15例16眼,包括眼表烧伤7例8眼、病毒性角膜炎3例3眼、Stevens-Johnson综合征1例l眼、眼外伤2例2眼、真菌性和细菌性角膜溃疡接受角膜移植术后血管化角膜白斑各1例1眼,所有患者均为男性,平均年龄(50.4±13.0)岁.纳入的患眼中14眼接受过治疗性角膜移植术1次或以上,有明确青光眼病史者7眼,人工晶状体(IOL)植入术后5眼,无晶状体眼4眼.术前最佳矫正视力(BCVA)为0.05者1眼,数指/眼前者7眼,手动/眼前者8眼.所有患眼均行波士顿Ⅰ型人工角膜移植术,术后定期观察术眼BCVA、并发症和人工角膜在位眼数.患者随访19～84个月,平均(47.5±23.8)个月.结果 术中根据术眼病变进行波士顿人工角膜移植术或联合手术,包括联合晶状体或IOL摘出术、虹膜切除术、前部玻璃体及增生膜切割术,波士顿人工角膜移植术过程均顺利,未见术中并发症发生.术后1个月14眼视力提高,其中3眼BCVA≥1.0,4眼0.5≤BCVA＜1.0,7眼0.1≤BCVA＜0.5,而其他2眼因术前有青光眼视神经损伤,故视力无提高.末次复诊时视力保持在0.1以上者9眼.术后常见并发症为人工角膜后膜(RMP)形成7眼,角膜溶解6眼,青光眼4眼;发生严重真菌性角膜溃疡、细菌性眼内炎和人工角膜脱出各1眼,为保留眼球均行穿透角膜移植术,取出人工角膜.术后13眼人工角膜在位.结论 波士顿Ⅰ型人工角膜可用于治疗不适合常规角膜移植术的严重角膜盲,术后长期随访、及时发现并有效处理并发症是保持人工角膜移植术成功和保存患者视力的关键.
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