Moving from PROMs to POEMs for Glaucoma Care: A Qualitative Scoping Exercise

Purpose. Patient-reported outcome measures (PROMs) are accepted widely as important outcomes in comparative effectiveness research. Over 30 PROMs have been described for use in glaucoma research, but their role in routine care is undefined. Our study explores the views of patients with glaucoma and their carers on the feasibility and content of a glaucoma PROM for use in day-to-day clinical practice. Methods. Focus groups were held with 71 participants facilitated by 23 staff working in the field of ophthalmology. Comparisons were made among themes derived from this exercise using simple thematic analysis and currently available health-related quality of life (HRQoL) instruments. Results. Participants were supportive of reporting their outcomes if the instrument was short, practical, and useful. Potential barriers to the use of PROMs, including bureaucratic overload and accessibility issues, were identified. Measuring health outcome and patient experience was important to participants. No freely available instrument covers all the domains identified, particularly knowledge and understanding. A novel instrument, a glaucoma patient-reported outcome and experience measure (POEM) is proposed. This addresses three aspects of outcome (fear of blindness, acceptability of treatment/side effects, and impact on daily life), and three aspects of experience (safety, respect, and understanding). Conclusions. Using PROMs routinely in the management of glaucoma presents significant challenges. Although current instruments (questionnaires) cover many of the participants' key domains, no single instrument covered them all. Further research is required to determine the feasibility (resources required), and validity and reliability of the proposed glaucoma POEM in clinical care.     

Detection and measurement of clinically meaningful visual field progression in clinical trials for glaucoma

Glaucomatous visual field progression has both personal and societal costs and therefore has a serious impact on quality of life. At the present time, intraocular pressure (IOP) is considered to be the most important modifiable risk factor for glaucoma onset and progression. Reduction of IOP has been repeatedly demonstrated to be an effective intervention across the spectrum of glaucoma, regardless of subtype or disease stage. In the setting of approval of IOP-lowering therapies, it is expected that effects on IOP will translate into benefits in long-term patient-reported outcomes. Nonetheless, the effect of these medications on IOP and their associated risks can be consistently and objectively measured. This helps to explain why regulatory approval of new therapies in glaucoma has historically used IOP as the outcome variable. Although all approved treatments for glaucoma involve IOP reduction, patients frequently continue to progress despite treatment. It would therefore be beneficial to develop treatments that preserve visual function through mechanisms other than lowering IOP. The United States Food and Drug Administration (FDA) has stated that they will accept a clinically meaningful definition of visual field progression using Glaucoma Change Probability criteria. Nonetheless, these criteria do not take into account the time (and hence, the speed) needed to reach significant change. In this paper we provide an analysis based on the existing literature to support the hypothesis that decreasing the rate of visual field progression by 30% in a trial lasting 12–18 months is clinically meaningful. We demonstrate that a 30% decrease in rate of visual field progression can be reliably projected to have a significant effect on health-related quality of life, as defined by validated instruments designed to measure that endpoint.     

Patient-reported outcomes in patients with vitreous floaters: A systematic literature review

Seeking treatment for bothersome vitreous floaters is patient driven. To measure the impact of floaters and treatment on an individual’s quality of life, patient-reported outcome measurements (PROMs) are essential. We review all studies using a PROM for patients with floaters. We evaluated content coverage against quality-of-life domains previously identified in other ophthalmic disorders, and against a qualitative study investigating quality-of-life issues in patients with floaters. We assessed measurement properties of PROMs using an extensive range of psychometric quality criteria. We identified 59 studies using 28 different PROMs. Many PROMs were not specifically developed for patients with floaters. Floater-specific PROMs were mostly based on content validation from an ophthalmologist or researcher perspective; two included a patient perspective. Using the outcomes of the qualitative study, we found that the floater-specific PROMs were narrow in their content coverage, with most items relating to visual symptoms and activity limitations. Testing the psychometric quality of PROMs was rare, and when employed mostly limited to responsiveness and known group validity. The remarkable high number of floater-specific PROMs reveals a need for such measurements in ophthalmology. Unfortunately, reporting on psychometric quality is limited, and content development is most often done without patient involvement.     

抗青光眼手术的利与弊

 青光眼是终生性疾病和不可逆性致盲眼病,即使经过恰当治疗仍不能恢复原有的正常视功能,只能延缓病情进展,而不能将其治愈。目前青光眼的治疗主要包括药物、激光和手术手段,因人而异地将眼压降低,尽量达到每位患者的“目标眼压”。目前常用的抗青光眼手术是小梁切除术,能明显降低眼压,控制眼压波动,成功率较高,但仍存在一定风险和难以预料的手术并发症,医生和患者均需要慎重选择。影响手术效果的因素较多,尤其是难治性青光眼更需要医生积极妥当处理。（眼科,2014, 23： 288-后插II）     

Ahmed青光眼阀植入术后盘周包裹囊状泡的手术疗效

目的 评价Ahmed青光眼阀植入术后盘周包裹囊状泡的手术疗效.方法 回顾性系列病例研究.收集13例经Ahmed青光眼阀植入术后盘周纤维增殖形成并包裹囊壁致眼压升高患者的临床资料,进行回顾性分析.患者眼压升高时间为青光眼阀植入术后3周至5个月,平均2个月,经检查Ahmed青光眼阀的引流盘和管位置均正常,管口无堵塞物,于眼球赤道部引流盘所在位置发现局限隆起包裹的囊状泡.所有患者均行包裹囊壁切除术,术中结膜瓣下使用丝裂霉素C治疗,并将剪除的纤维组织送病理检查,观察术后早期和中晚期患者的眼压和病程转归情况.结果 引流盘周包裹囊壁切除术后1个月,所有患者眼压均在正常范围内,手术成功率100%.术后随访3～20个月,3例患者在未加用任何降眼压药物的情况下,眼压控制在正常范围内;6例患者在使用2或3种降眼压药物的情况下,眼压控制在正常范围内;3例患者用药物仍无法控制眼压,需要进一步手术治疗.其中,57岁及以上患者的手术完全成功率为75%(3/4),37岁及以下患者的手术完全成功率为0(0/8).结论 手术切除包裹囊壁是治疗Ahmed青光眼阀植入术后引流盘周包裹囊状泡的一种有效方法,老年患者的中、长期手术疗效相对好于年轻患者.     

拉坦前列素滴眼液治疗真性小眼球继发闭角型青光眼的疗效观察

目的 探讨拉坦前列素滴眼液对真性小眼球继发闭角型青光眼的治疗效果.方法 系列病例研究.选择2009年6月至2010年7月在首都医科大学附属北京同仁医院眼科中心收治的真性小眼球继发闭角型青光眼5例共9只眼,使用了0.005%拉坦前列素滴眼液或激光虹膜周切后联合0.005%拉坦前列素滴眼液,随访观察3～16个月,对其视力及眼压、眼底及视野等进行了监测.结果 真性小眼球继发闭角型青光眼5例患者共9只眼在治疗后眼压控制在10～20mmHg之间,视力无下降,视野及眼底杯/盘比无进展.结论 使用0.005%拉坦前列素滴眼液治疗真性小眼球继发闭角型青光眼是安全有效地方法,避免了小梁切除术后可能出现的眼部并发症.

Abstract：

Objective To study the effect of latanoprost on the trealment of nanophthalmos combined angle closure glaucoma. Methods Clinical case series. From June 2009 to July 2010, in Beijing Tongren Eye Center and Beijing Tongren Hospital, five patients (9 eyes) diagnosed as nanophtalmos combined with angle closure glaucoma were treated with latanoprost eye drops and followed up 3 to 16 months for clinical evaluation. The clinical outcomes included visual acuity, IOP, fundus examination and visual field examination. Results In 9 eyes, the IOP was controlled under normal level. The visual acuity, fundus examination and visual field examination did not vary from the baseline.Conclusions Latanoprost eye drops is effective and safe in the treatment of nanophthalmos combined with angle closure glaucoma.     

The critical role of the conjunctiva in glaucoma filtration surgery

This review considers the critical role of the conjunctiva in determining the success or failure of glaucoma filtration surgery. Glaucoma filtration surgery can be defined as an attempt to lower intraocular pressure (IOP) by the surgical formation of an artificial drainage pathway from the anterior chamber to the subconjunctival space. Many types of glaucoma filtration surgery have been developed since the first attempts almost 180 years ago. The wide range of new techniques and devices currently under investigation is testament to the limitations of current techniques and the need for improved therapeutic outcomes. Whilst great attention has been paid to surgical techniques and devices to create the drainage pathway, relatively little attention has been given to address the question of why drainage from such artificial pathways is often problematic. This is in contrast to normal drainage pathways which last a lifetime. Furthermore, the consequences of potential changes in aqueous humour properties induced by glaucoma filtration surgery have not been sufficiently addressed. The mechanisms by which aqueous fluid is drained from the subconjunctival space after filtration surgery have also received relatively little attention. We propose that factors such as the degree of tissue damage during surgery, the surrounding tissue reaction to any surgical implant, and the degree of disruption of normal aqueous properties, are all factors which influence the successful formation of long term drainage channels from the conjunctiva, and that these channels are the key to successful filtration surgery. In recent years it has been suggested that the rate of fluid drainage from the subconjunctival space is actually the determining factor in the resultant IOP reduction. Improved knowledge of aqueous humour induced changes in such drainage pathways has the potential to significantly improve the surgical management of glaucoma.We describe for the first time a novel type of drainage surgery which attempts to minimise surgical trauma to the overlying conjunctiva. The rationale is that a healthy conjunctiva allows drainage channels to form and less opportunity for inflammation and scar tissue formation which are a frequent cause of failure in glaucoma filtration surgery. Successful drainage over extended periods of time has been demonstrated in monkey and rabbit eyes. Long lasting drainage pathways were clearly associated with the presence of lymphatic drainage pathways. A new philosophy in glaucoma drainage surgery is proposed in which minimisation of surgical trauma to the conjunctiva and the encouragement of the development of conjunctival drainage pathways, particularly lymphatic pathways, are central pillars to a successful outcome in glaucoma filtration surgery.     

Early Manifest Glaucoma Trial: design and baseline data

Objectives

The Early Manifest Glaucoma Trial (EMGT) will evaluate the effectiveness of reducing intraocular pressure (IOP) in early, previously untreated open-angle glaucoma. Its secondary aims are to explore factors related to glaucoma progression and to study the natural history of the disease. This article describes the EMGT design and presents baseline data.

Subconjunctival Bevacizumab as an Adjunct to Trabeculectomy in Eyes with Refractory Glaucoma: A Case Series

This prospective observational case series study included 6 eyes of 6 consecutive glaucomatous patients. Each patient underwent trabeculectomy with mitomycin C, and received a 1.25 mg of subconjunctival bevacizumab injection at completion of the trabeculectomy. Study eyes included two with neovascular glaucoma, three with uveitic glaucoma, and one with secondary glaucoma following vitrectomy. All eyes had undergone failed glaucoma laser/surgical treatment or an intraocular surgical procedure. Intraocular pressure (IOP) at the following postoperative visits: preoperative, 1 week, 1 month, 2 months, 3 months, and 6 months, was measured. We also evaluated postoperative bleb findings and complications. IOP measured at each visit was 37.5±14.4 mmHg, 6.2±3.4 mmHg, 8.3±7.2 mmHg, 12.0±4.4 mmHg, 10.8±3.1 mmHg, and 12.2±3.3 mmHg, respectively, for each visit. All eyes had functioning blebs with normal IOP at postoperative 6 months with no additional IOP-lowering medication.     

Prevalence and characteristics of glaucoma among Korean adults

Purpose

The purpose of this study was to investigate the prevalence and characteristics of glaucoma in the population of the rural Korean town, Sangju.

Methods

Residents of Sangju aged greater than 50 years old were included in this study. Participants completed an interview examining their medical and ophthalmic history Information was collected on the participants'' uncorrected and best corrected vision scores, slit lamp examination results, angle width measurements using the Van Herick technique, gonioscopy if the angle width was less than 1 / 4 angle, intraocular pressure (IOP) assessed with the Goldmann applanation tonometry, optic disc examination results, and a visual field test results using frequency-doubling perimetry in cases in which glaucoma was suspected. Glaucoma was diagnosed according to the criteria described by the International Society for Geographic and Epidemiological Ophthalmology.

Results

1,118 residents aged greater than 50 years were examined initially from a population of 2,984 people. Of these, 671 subjects (60%) participated in this study. The prevalence of glaucoma was determined to be 3.4% (95% confidence interval [CI], 2.1-4.8). Open-angle glaucoma with low IOP was determined to be the most common form with a prevalence rate as high as 2.5% (95% CI, 1.8-3.7). Additionally, primary angle closure glaucoma was determined to have a prevalence rate of 0.3% (95% CI, 0.1-0.9). Open-angle glaucoma with low IOP accounted for 94.4% of the open-angle glaucoma cases.

Conclusions

The prevalence of glaucoma among the population of rural Sangju was 3.4%, and open-angle glaucoma with low IOP was the most common form accounting for 94.4% of the total number of cases.     

The impact of diabetic retinopathy: understanding the patient's perspective

Understanding the impact of a condition from the patient's perspective is important, and different types of patient-reported outcomes or instruments are available to help with this. This review article summarises the current evidence on the impact of diabetic retinopathy (DR) and its associated vision impairment on patient-reported outcomes. We have included research that has used a range of outcome measures to assess the impact of DR on generic health-related quality of life, utility, vision-functioning and vision-specific quality of life. This review also offers clarification on frequently misused psychometric terminologies to help clinicians and researchers better understand the literature associated with patient-reported outcome research. Overall, the evidence suggests that DR, particularly in its vision-threatening stages, has a substantial, negative impact on the patient. However, our understanding of the impact of DR is currently restricted due to limitations inherent in currently available patient-reported outcome measures. We conclude by discussing potential directions for future research in this area, such as item banking and computer adaptive testing.     

原发性开角型青光眼进展的危险因素研究概况

原发性开角型青光眼(POAG)进展的危险因素包括全身性及眼部因素,眼部因素包括眼压及非眼压因素.在以往的多中心研究中,眼压对于由高眼压症发展为POAG及其在POAG进展中的作用已经明确,而目前降低眼压也是临床惟一有效地延缓、控制青光眼视神经损害进展的主要因素.制定目标眼压,进行降眼压治疗尤其是控制昼夜眼压波动对于阻止青光眼进展非常重要.非眼压危险因素包括高龄、中央角膜厚度增厚、视乳头出血、晶状体囊膜剥脱征、初始的青光眼严重程度及双眼罹患青光眼等.其他因素包括近视、青光眼家族史、眼部低灌注压、低血压、心血管疾病、高血压、高血脂等血管或血液性因素.POAG进展的危险因素研究在一定程度上揭示了POAG的发病机制及临床发病规律,对于指导临床医师决定随诊频率、选择治疗方案及提高治疗效率意义重大.     

FP-7/FP-8 Ahmed青光眼引流阀植入治疗儿童难治性青光眼的临床评价

背景 临床研究已证实FP-7/FP-8 Ahmed青光眼引流阀治疗成人难治性青光眼有效且安全,但由于儿童青光眼的病理机制复杂及其临床表现的多样性,采用FP-7/FP-8 Ahmed青光眼引流阀治疗儿童难治性青光眼的疗效和安全性评价较少. 目的 评价FP-7/FP-8 Ahmed青光眼引流阀治疗儿童难治性青光眼的临床效果.方法 采用回顾性系列病例观察研究设计,纳入2008年10月至2011年4月于沧州市中心医院行FP-7/FP-8 Ahmed青光眼引流阀植入术的儿童青光眼患者26例30眼,患者年龄为4个月～16.5岁,包括先天性青光眼小梁/房角切开术后高眼压、晚期先天性青光眼、无晶状体眼或人工晶状体植入术后青光眼、外伤性青光眼和Sturge-Weber综合征.分别于术后1周及1、6、12、24个月复查,观察术眼术后眼压、手术并发症及手术成功率. 结果 患者术前平均眼压为（36.93±177;10.56） mmHg（1 mmHg=0.133 kPa）,术后1周及1、6、12、24个月眼压分别为（13.13±177;3.34）、（14.13±177;3.15）、（15.93±177;4.76）、（17.96±177;5.37）、（19.74±177;5.43） mmHg,不同时间点的眼压整体比较差异有统计学意义（F=58.929,P＜0.05）;与术前眼压值比较,术后1周及1、6、12、24个月术眼眼压均明显下降,差异均有统计学意义（t=11.641、11.458、10.688、7.988、8.018,P＜0.05）.本组术眼术后1周及1、6、12、24个月的累积总成功率分别为100％、96.67％、93.21％、85.76％和71.46％.术后共有8眼出现轻度并发症,包括浅前房4眼、引流管阻塞1眼、前房积血2眼和引流管暴露1眼,经药物或手术治疗后痊愈,未发现术后严重并发症.结论 FP-7/FP-8 Ahmed青光眼引流阀植入术治疗儿童难治性青光眼有效且安全,可作为儿童难治性青光眼的首选手术方式之一.     

无玻璃体眼并发难治性青光眼的治疗策略及随访一年结果分析

目的 评价无玻璃体眼并发难治性青光眼的手术治疗方法及效果,分析其治疗策略。方法 回顾性病例研究。分析绵阳市中心医院眼科2008 年1月至2010年12月因玻璃体切除术后或硅油取出术后并发难治性青光眼患者17例,其中5例采用复合小梁切除手术（Ａ组）,8例采用青光眼引流阀植入手术（Ｂ组）,4例因光感丧失采用810激光透巩膜睫状体光凝治疗（C组）。分析各组随访观察1年的眼压控制情况及并发症情况。采用重复测量的方差分析。结果 各组在术后早期眼压均控制良好,术后1年Ａ组术眼眼压平均为（30.44±4.23）mmHg,联合降眼压药物治疗后可将眼压控制在正常范围;B组平均眼压为（20.78±4.54）mmHg;C组平均眼压为（30.79±3.23）mmHg,达到缓解疼痛目的。与治疗前比较,各组眼压明显降低（F=32.20、46.81、27.69,P<0.01）。3组术后均无严重并发症。结论 玻璃体切除术后或硅油取出术后并发青光眼因有多次手术史,结膜瘢痕重,属于难治性青光眼,常规复合小梁切除手术因滤过道瘢痕化,远期效果不理想,需联合药物治疗;青光眼引流阀是安全有效的治疗方法,远期降眼压效果理想;对于光感消失患者810激光透巩膜睫状体光凝治疗术后降压药效果确切,是很好的补充手段。     

运动与眼压

早在20世纪60年代,就有研究者发现运动可以降低青光眼患者的眼压。不同的运动方式、不同的运动强度及运动后的时间对降眼压的效应不同。青光眼患者和正常人运动后的降眼压幅度和持续时间存在一定的差异。运动降低眼压的机制与去甲肾上腺素浓度降低、胶体渗透压增加、一氧化氮与内皮素及β2受体基因多态性等因素有关。临床眼科医师在对青光眼患者进行药物和手术治疗的同时,应鼓励患者尝试运动疗法,如散步、慢跑、骑单车等。     

Outcomes of small-incision cataract surgery in eyes with preexisting Ahmed Glaucoma Valves

PURPOSE: To investigate outcomes of phacoemulsification in eyes with functioning Ahmed Glaucoma Valves (AGVs). DESIGN: Observational case series. METHODS: We reviewed records of 19 patients (23 eyes) who had a clear-cornea phacoemulsification >/=3 months after insertion of an AGV between 1997 and 2002. The main outcome measures were intraocular pressure (IOP) control, number of medications, complications, and further glaucoma surgery. RESULTS: The median interval between AGV surgery and phacoemulsification was 0.7 years with an average (+/-SD) follow-up time of 1.6 (+/-0.6) years (range: 0.9 to 3.0 years). Four eyes (17%) had an IOP increase >10 mm Hg on day one. The mean IOP or number of medications did not significantly change after phacoemulsification at one month or thereafter (P > .05). One eye (4%) required a second AGV. CONCLUSIONS: Small-incision cataract surgery is consistent with maintenance of IOP control in eyes with functioning AGV. A minority of the eyes will require repeat glaucoma surgery.     

Test retest variability of TonoPen AVIA

The study was conducted to evaluate the intra-session repeatability of Tonopen AVIA (TPA). 180 eyes of 180 patients (50 eyes with glaucoma, 130 eyes of controls) were recruited for this observational study. The mean age of patients enrolled in the study was 43.9 ± 16.7 yrs (84 males, 96 females). Mean IOP recorded with Tonopen AVIA was 19.5 ± 9.5 mmHg, 19.4 ± 9.6 mmHg and 19.3 ± 9.2 mmHg, respectively in the first, second and third instances (P = 0.656). The intraclass correlation coefficient (ICC) ranged from 0.996 (95% CI: 0.956 - 0.998) for glaucoma subjects to 0.958 (95% CI: 0.934 - 0.975) for controls. The coefficient of variation in the study population ranged from 3.47% (glaucoma patients) to 8.10% (healthy controls), being 6.07% overall. The coefficient of repeatability varied between 2.96 (glaucoma patients), 3.35 (healthy controls) to 3.24 (overall). Thus, the Tonopen Avia shows good intrasessional repeatability of IOP in both glaucomatous patients and healthy subjects.     

接觸式二極管激光治瘵新生血管性青光眼97例

目的 评价二机管激光经巩膜睫状体光凝治疗新生血管性青光眼的有效性和安全性,同时观察近期和远期疗效。方法对97例98眼新生血管性青光眼施行接触式二机管激光以巩膜睫状体光凝,术后观察并记录视力、眼压、结膜、角膜、前房、虹膜、晶状体等情况,随访时间3月～4年。结果 术后眼压近期平均为27.12mmHg,远期为31.24mmHg,与术前相比均有显著性差异(P<0.01)。并发症有色素膜炎、前房出血等。结论 接触式二机管激光经巩膜睫状体光凝是治疗新生血管性青光眼有效、安全、简便的方法。