PDF(Pubmed)
Abstract：
Eyes sustaining open globe trauma are at high risk of severe visual impairment. Proliferative vitreoretinopathy is the most common cause of retinal detachment and visual loss in eyes with open globe trauma. There is evidence from experimental studies and pilot clinical trials that the use of adjunctive steroid medication triamcinolone acetonide can reduce the incidence of proliferative vitreoretinopathy and improve outcomes of surgery for open globe trauma.
The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study aimed to investigate the clinical effectiveness of adjunctive triamcinolone acetonide given at the time of vitreoretinal surgery for open globe trauma.
A phase 3 multicentre double-masked randomised controlled trial randomising patients undergoing vitrectomy following open globe trauma to either adjunctive triamcinolone acetonide or standard care.
Hospital vitreoretinal surgical services dealing with open globe trauma.
Patients undergoing vitrectomy surgery who had sustained open globe trauma.
Triamcinolone acetonide 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml sub-Tenon\'s or standard vitreoretinal surgery and postoperative care.
The primary outcome was the proportion of patients with at least 10 letters of improvement in corrected visual acuity at six months. Secondary outcomes included retinal detachment secondary to proliferative vitreoretinopathy, retinal reattachment, macula reattachment, tractional retinal detachment, number of operations, hypotony, elevated intraocular pressure and quality of life. Health-related quality of life was assessed using the EuroQol Five Domain and Visual Function Questionnaire 25 questionnaires.
A total of 280 patients were randomised; 129 were analysed from the control group and 130 from the treatment group. The treatment group appeared, by chance, to have more severe pathology on presentation. The primary outcome (improvement in visual acuity) and principal secondary outcome (change in visual acuity) did not demonstrate any treatment benefit for triamcinolone acetonide. The proportion of patients with improvement in visual acuity was 47% for triamcinolone acetonide and 43% for standard care (odds ratio 1.03, 95% confidence interval 0.61 to 1.75, p = 0.908); the baseline adjusted mean difference in the six-month change in visual acuity was -2.65 (95% confidence interval -9.22 to 3.92, p = 0.430) for triamcinolone acetonide relative to control. Similarly, the secondary outcome measures failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal reattachment and stable macular retinal reattachment, outcomes for the treatment group were significantly worse for triamcinolone acetonide at the 5% level (respectively, odds ratio 0.59, 95% confidence interval 0.36 to 0.99, p = 0.044 and odds ratio 0.59, 95% confidence interval 0.35 to 0.98, p = 0.041) compared with control in favour of control. The cost of the intervention was £132 per patient. Health economics outcome measures (Early Treatment Diabetic Retinopathy Study, Visual Function Questionnaire 25 and EuroQol Five Dimensions) did not demonstrate any significant difference in quality-adjusted life-years.
The use of combined intraocular and sub-Tenon\'s capsule triamcinolone acetonide is not recommended as an adjunct to vitrectomy surgery for intraocular trauma. Secondary outcome measures are suggestive of a negative effect of the adjunct, although the treatment group appeared to have more severe pathology on presentation.
The use of alternative adjunctive medications in cases undergoing surgery for open globe trauma should be investigated. Refinement of clinical grading and case selection will enable better trail design for future studies.
This trial is registered as ISRCTN 30012492, EudraCT number 2014-002193-37, REC 14/LNO/1428, IRAS 156358, Local R&D registration CHAD 1031.
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (12/35/64) and will be published in full in Health Technology Assessment; Vol. 27, No. 12. See the NIHR Journals Library website for further project information.
Despite advances in surgical techniques, eye trauma remains a leading cause of blindness and visual impairment. The main cause of trauma is a scarring process within the eye – proliferative vitreoretinopathy. There is good evidence from laboratory work and small-scale clinical studies that the addition of a steroid medication, triamcinolone acetonide, given in and around the eye at the time of surgery for eye trauma, can reduce the incidence of proliferative vitreoretinopathy scarring and improve the outcomes of surgery. The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study was a multicentre clinical trial designed to test the use of triamcinolone acetonide as an addition to surgery to improve outcomes in eyes with ‘open globe’ penetrating injuries. A total of 280 patients were recruited and randomised to receive standard surgery or surgery with the additional steroid (triamcinolone acetonide). No benefit was found from the addition of the steroid medication. The addition of steroid medication was not good value for money. Secondary outcome measures suggested that triamcinolone acetonide may have had a negative effect on outcomes, although this may have been due to the presence of more severe cases amongst the patients allocated to receive the additional steroid (triamcinolone acetonide). The use of adjunctive triamcinolone acetonide in eye trauma cases undergoing surgery is therefore not recommended. Future studies with different additional medications and/or more targeted case selection are indicated to improve outcomes for eyes experiencing penetrating trauma.
The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study aimed to investigate the clinical effectiveness of adjunctive triamcinolone acetonide given at the time of vitreoretinal surgery for open globe trauma.
A phase 3 multicentre double-masked randomised controlled trial randomising patients undergoing vitrectomy following open globe trauma to either adjunctive triamcinolone acetonide or standard care.
Hospital vitreoretinal surgical services dealing with open globe trauma.
Patients undergoing vitrectomy surgery who had sustained open globe trauma.
Triamcinolone acetonide 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml sub-Tenon\'s or standard vitreoretinal surgery and postoperative care.
The primary outcome was the proportion of patients with at least 10 letters of improvement in corrected visual acuity at six months. Secondary outcomes included retinal detachment secondary to proliferative vitreoretinopathy, retinal reattachment, macula reattachment, tractional retinal detachment, number of operations, hypotony, elevated intraocular pressure and quality of life. Health-related quality of life was assessed using the EuroQol Five Domain and Visual Function Questionnaire 25 questionnaires.
A total of 280 patients were randomised; 129 were analysed from the control group and 130 from the treatment group. The treatment group appeared, by chance, to have more severe pathology on presentation. The primary outcome (improvement in visual acuity) and principal secondary outcome (change in visual acuity) did not demonstrate any treatment benefit for triamcinolone acetonide. The proportion of patients with improvement in visual acuity was 47% for triamcinolone acetonide and 43% for standard care (odds ratio 1.03, 95% confidence interval 0.61 to 1.75, p = 0.908); the baseline adjusted mean difference in the six-month change in visual acuity was -2.65 (95% confidence interval -9.22 to 3.92, p = 0.430) for triamcinolone acetonide relative to control. Similarly, the secondary outcome measures failed to show any treatment benefit. For two of the secondary outcome measures, stable complete retinal reattachment and stable macular retinal reattachment, outcomes for the treatment group were significantly worse for triamcinolone acetonide at the 5% level (respectively, odds ratio 0.59, 95% confidence interval 0.36 to 0.99, p = 0.044 and odds ratio 0.59, 95% confidence interval 0.35 to 0.98, p = 0.041) compared with control in favour of control. The cost of the intervention was £132 per patient. Health economics outcome measures (Early Treatment Diabetic Retinopathy Study, Visual Function Questionnaire 25 and EuroQol Five Dimensions) did not demonstrate any significant difference in quality-adjusted life-years.
The use of combined intraocular and sub-Tenon\'s capsule triamcinolone acetonide is not recommended as an adjunct to vitrectomy surgery for intraocular trauma. Secondary outcome measures are suggestive of a negative effect of the adjunct, although the treatment group appeared to have more severe pathology on presentation.
The use of alternative adjunctive medications in cases undergoing surgery for open globe trauma should be investigated. Refinement of clinical grading and case selection will enable better trail design for future studies.
This trial is registered as ISRCTN 30012492, EudraCT number 2014-002193-37, REC 14/LNO/1428, IRAS 156358, Local R&D registration CHAD 1031.
This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (12/35/64) and will be published in full in Health Technology Assessment; Vol. 27, No. 12. See the NIHR Journals Library website for further project information.
Despite advances in surgical techniques, eye trauma remains a leading cause of blindness and visual impairment. The main cause of trauma is a scarring process within the eye – proliferative vitreoretinopathy. There is good evidence from laboratory work and small-scale clinical studies that the addition of a steroid medication, triamcinolone acetonide, given in and around the eye at the time of surgery for eye trauma, can reduce the incidence of proliferative vitreoretinopathy scarring and improve the outcomes of surgery. The Adjunctive Steroid Combination in Ocular Trauma or ASCOT study was a multicentre clinical trial designed to test the use of triamcinolone acetonide as an addition to surgery to improve outcomes in eyes with ‘open globe’ penetrating injuries. A total of 280 patients were recruited and randomised to receive standard surgery or surgery with the additional steroid (triamcinolone acetonide). No benefit was found from the addition of the steroid medication. The addition of steroid medication was not good value for money. Secondary outcome measures suggested that triamcinolone acetonide may have had a negative effect on outcomes, although this may have been due to the presence of more severe cases amongst the patients allocated to receive the additional steroid (triamcinolone acetonide). The use of adjunctive triamcinolone acetonide in eye trauma cases undergoing surgery is therefore not recommended. Future studies with different additional medications and/or more targeted case selection are indicated to improve outcomes for eyes experiencing penetrating trauma.
摘要：
■眼睛持续开放的眼球创伤是严重视力障碍的高风险。增殖性玻璃体视网膜病变是眼球开放性创伤引起的视网膜脱离和视力丧失的最常见原因。来自实验研究和初步临床试验的证据表明，使用辅助类固醇药物曲安奈德可以减少增生性玻璃体视网膜病变的发生率，并改善开放性全球创伤手术的预后。
■在眼外伤或ASCOT研究中的辅助类固醇组合旨在研究在玻璃体视网膜手术治疗开放性眼球外伤时给予曲安奈德辅助治疗的临床有效性。
■一项3期多中心双掩蔽随机对照试验，将接受玻璃体切割手术的患者随机分配给眼球开放性创伤后给予曲安奈德辅助治疗或标准治疗。
■医院玻璃体视网膜手术服务处理开放性地球创伤。
■接受玻璃体切割手术的患者遭受了开放性眼球创伤。
■曲安奈德4毫克/0.1毫升进入玻璃体腔和40毫克/1毫升Tenon或标准玻璃体视网膜手术和术后护理。
■主要结果是六个月时矫正视力至少有10个字母改善的患者比例。次要结果包括增生性玻璃体视网膜病变继发的视网膜脱离，视网膜复位,黄斑复位,牵引性视网膜脱离,操作次数,矮个子,高眼压和生活质量。使用EuroQol五域和视觉功能问卷25问卷评估与健康相关的生活质量。
■共有280名患者被随机分组，其中129名来自对照组，130名来自治疗组。治疗组出现,偶然,出现更严重的病理。主要结局（视力改善）和主要次要结局（视力变化）未显示曲安奈德的任何治疗益处。曲安奈德视力改善的患者比例为47％，标准治疗为43％（比值比1.03，95％置信区间0.61至1.75，p=0.908）；曲安奈德相对于对照组，六个月视力变化的基线调整平均差为-2.65（95％置信区间-9.22至3.92，p=0.430）。同样，次要结局指标未能显示任何治疗获益.对于两个次要结果指标，稳定的完全视网膜复位和稳定的黄斑视网膜复位，在5%的水平下，曲安奈德治疗组的结局明显更差(分别是，比值比0.59，95％置信区间0.36至0.99，p=0.044，比值比0.59，95％置信区间0.35至0.98，p=0.041）与对照组相比。干预费用为每位患者132英镑。健康经济学结果测量(早期治疗糖尿病视网膜病变研究，视觉功能问卷25和EuroQol五个维度）在质量调整后的生命年中没有任何显着差异。
■不推荐使用眼内联合Tenon's下胶囊曲安奈德作为眼内创伤玻璃体切割手术的辅助手段。次要结果指标提示附属物的负面影响，尽管治疗组出现更严重的病理表现。
■应研究在开放性地球创伤手术中使用替代辅助药物的情况。临床分级和病例选择的细化将为未来的研究提供更好的试验设计。
■该试验注册为ISRCTN30012492，EudraCT编号2014-002193-37，REC14/LNO/1428，IRAS156358，本地研发注册CHAD1031。
■该项目由国家卫生和护理研究所（NIHR）卫生技术评估计划（12/35/64）资助，并将在《卫生技术评估》中全文发表；卷。27号12.有关更多项目信息，请参阅NIHR期刊库网站。
尽管外科技术有了进步,眼外伤仍然是失明和视力障碍的主要原因。创伤的主要原因是眼睛内的瘢痕形成过程-增生性玻璃体视网膜病变。实验室工作和小规模临床研究有很好的证据表明，添加类固醇药物，曲安奈德,在眼外伤手术时给予眼睛内外，可降低增生性玻璃体视网膜病变瘢痕形成的发生率,提高手术效果。眼外伤或ASCOT研究中的辅助类固醇组合是一项多中心临床试验，旨在测试曲安奈德作为手术的补充使用，以改善患有“开放眼球”穿透性损伤的眼睛的预后。总共招募了280名患者，并随机接受标准手术或附加类固醇（曲安奈德）手术。没有发现添加类固醇药物的益处。添加类固醇药物不是物有所值。次要结局指标表明曲安奈德可能对结局产生负面影响，尽管这可能是由于分配接受额外类固醇（曲安奈德）的患者中出现了更严重的病例。因此，不建议在接受手术的眼外伤病例中使用曲安奈德辅助治疗。未来研究采用不同的额外药物和/或更有针对性的病例选择，以改善患有穿透性创伤的眼睛的预后。
■在眼外伤或ASCOT研究中的辅助类固醇组合旨在研究在玻璃体视网膜手术治疗开放性眼球外伤时给予曲安奈德辅助治疗的临床有效性。
■一项3期多中心双掩蔽随机对照试验，将接受玻璃体切割手术的患者随机分配给眼球开放性创伤后给予曲安奈德辅助治疗或标准治疗。
■医院玻璃体视网膜手术服务处理开放性地球创伤。
■接受玻璃体切割手术的患者遭受了开放性眼球创伤。
■曲安奈德4毫克/0.1毫升进入玻璃体腔和40毫克/1毫升Tenon或标准玻璃体视网膜手术和术后护理。
■主要结果是六个月时矫正视力至少有10个字母改善的患者比例。次要结果包括增生性玻璃体视网膜病变继发的视网膜脱离，视网膜复位,黄斑复位,牵引性视网膜脱离,操作次数,矮个子,高眼压和生活质量。使用EuroQol五域和视觉功能问卷25问卷评估与健康相关的生活质量。
■共有280名患者被随机分组，其中129名来自对照组，130名来自治疗组。治疗组出现,偶然,出现更严重的病理。主要结局（视力改善）和主要次要结局（视力变化）未显示曲安奈德的任何治疗益处。曲安奈德视力改善的患者比例为47％，标准治疗为43％（比值比1.03，95％置信区间0.61至1.75，p=0.908）；曲安奈德相对于对照组，六个月视力变化的基线调整平均差为-2.65（95％置信区间-9.22至3.92，p=0.430）。同样，次要结局指标未能显示任何治疗获益.对于两个次要结果指标，稳定的完全视网膜复位和稳定的黄斑视网膜复位，在5%的水平下，曲安奈德治疗组的结局明显更差(分别是，比值比0.59，95％置信区间0.36至0.99，p=0.044，比值比0.59，95％置信区间0.35至0.98，p=0.041）与对照组相比。干预费用为每位患者132英镑。健康经济学结果测量(早期治疗糖尿病视网膜病变研究，视觉功能问卷25和EuroQol五个维度）在质量调整后的生命年中没有任何显着差异。
■不推荐使用眼内联合Tenon's下胶囊曲安奈德作为眼内创伤玻璃体切割手术的辅助手段。次要结果指标提示附属物的负面影响，尽管治疗组出现更严重的病理表现。
■应研究在开放性地球创伤手术中使用替代辅助药物的情况。临床分级和病例选择的细化将为未来的研究提供更好的试验设计。
■该试验注册为ISRCTN30012492，EudraCT编号2014-002193-37，REC14/LNO/1428，IRAS156358，本地研发注册CHAD1031。
■该项目由国家卫生和护理研究所（NIHR）卫生技术评估计划（12/35/64）资助，并将在《卫生技术评估》中全文发表；卷。27号12.有关更多项目信息，请参阅NIHR期刊库网站。
尽管外科技术有了进步,眼外伤仍然是失明和视力障碍的主要原因。创伤的主要原因是眼睛内的瘢痕形成过程-增生性玻璃体视网膜病变。实验室工作和小规模临床研究有很好的证据表明，添加类固醇药物，曲安奈德,在眼外伤手术时给予眼睛内外，可降低增生性玻璃体视网膜病变瘢痕形成的发生率,提高手术效果。眼外伤或ASCOT研究中的辅助类固醇组合是一项多中心临床试验，旨在测试曲安奈德作为手术的补充使用，以改善患有“开放眼球”穿透性损伤的眼睛的预后。总共招募了280名患者，并随机接受标准手术或附加类固醇（曲安奈德）手术。没有发现添加类固醇药物的益处。添加类固醇药物不是物有所值。次要结局指标表明曲安奈德可能对结局产生负面影响，尽管这可能是由于分配接受额外类固醇（曲安奈德）的患者中出现了更严重的病例。因此，不建议在接受手术的眼外伤病例中使用曲安奈德辅助治疗。未来研究采用不同的额外药物和/或更有针对性的病例选择，以改善患有穿透性创伤的眼睛的预后。
