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波前引导 LASIK 用于老花眼近视患者的单视治疗

2026年6月25日 更新者：AMO Development, LLC

波前引导 LASIK 单视治疗近视老花眼的批准后研究

这项研究将是一项为期 12 个月、前瞻性、多中心、开放标签、非比较、非随机临床研究，在 8 至 14 个地点进行。 总共将招募 383 名受试者，以获得大约 268 名接受治疗的受试者，从而导致至少 241 名受试者在屈光稳定性方面可评估。 签署知情同意书后，可以安排双眼符合所有纳入和排除标准的受试者进行手术。 每只手术眼的随访时间表都相同。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

219

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90024
        • Maloney Vision Institute
    • Illinois
      • Chicago、Illinois、美国、60602
        • Kraff Eye Institute
    • Nevada
      • Las Vegas、Nevada、美国、89145
        • Center for Sight
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • Coleman Vision
    • South Dakota
      • Sioux Falls、South Dakota、美国、57108
        • Vance Thompson Vision
    • Tennessee
      • Goodlettsville、Tennessee、美国、37072
        • Loden Vision Centers
    • Texas
      • Houston、Texas、美国、77027
        • Berkeley Eye Institute, P.A.
      • Hurst、Texas、美国、76054
        • Texas Eye & Laser Center
    • Utah
      • Ogden、Utah、美国、84403
        • Utah Eye Center
    • Virginia
      • Fairfax、Virginia、美国、22031
        • The Eye Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 签署知情同意书和 HIPAA 授权。
  2. 入组时至少 40 岁（签署知情同意书的日期）。
  3. 基于为治疗选择的 iDesign 屈光度（“4.0 毫米 Rx 计算值”，12.5 毫米），受试者双眼的屈光不正必须是近视，有或没有散光高达 -6.00 D 等效球镜 (SE)，柱镜高达-3.00 D 和他们的非优势眼的最小术前近视至少与他们的目标近视保持一样大。
  4. 必须至少有一只眼睛需要接受近视治疗。
  5. 根据术前中央角膜厚度测量减去要消融的最大治疗深度（由 iDesign 计算加上预期的角膜瓣厚度），预计基质床厚度至少为 250 微米。
  6. 距离 最佳眼镜矫正视力 (BSCVA) 为 20/20 或更好。
  7. 在 40 厘米处需要 +1.25 D 或更多但不大于 +2.00 D 的附加功率。
  8. 散瞳和显性折射球体之间的差异小于或等于 ±0.50 D。

  9. 稳定的屈光不正（基于术前明显屈光前至少 12 个月的先前检查、医疗记录、验光或处方），定义为小于或等于的变化

    • MRSE 中的 0.50 D（球体和圆柱体）。

  10. 在过去 4 周内有隐形眼镜佩戴史的受试者必须停止佩戴镜片，以根据以下内容证明屈光稳定性（屈光稳定性定义为显性屈光球面和柱面的变化不超过 0.50 D，以及测量之间的平均角膜曲率测量法）：在知情同意过程完成并且受试者被纳入研究后：

    • 硬性或长戴型隐形眼镜（复曲面或球面）必须摘除至少 3 周，软性隐形眼镜（复曲面或球面）必须摘除至少 2 周，然后才能进行首次验光以确定稳定性。
    • 在指定时间内不戴隐形眼镜后，必须至少间隔 7 天进行两次连续的明显屈光和角膜曲率读数
    • I 如果受试者/眼睛符合屈光稳定性标准，则在手术前 2 周内不允许佩戴隐形眼镜，除非需要测试单眼视力接受度，如下文研究程序，隐形眼镜试用部分所述 注意：屈光稳定性需要仅在术前评估期间确认一次

  11. 明显折射（针对光学无限远进行调整）与选择用于治疗的 iDesign 系统折射之间的一致性，如下所示：

    • 球当量：差值小于 0.625 D。
    • 圆柱：差值小于等于0.5D。
    • 圆柱轴公差：如果输入 iDesign 系统的清单圆柱体或选择用于处理的 iDesign 圆柱体小于 0.5 D，则不需要轴一致性。 当两个圆柱体的幅度都至少为 0.5 D 时，由 iDesign 系统确定的轴公差会根据两个圆柱体的平均幅度从 15 度 (0.5 D) 线性减小到 7.5 度 (7.0 D)。 注意：如果轴公差不在计算范围内，iDesign 系统会发出警告，并且此检查可能不会用于治疗计划。
  12. 愿意并能够在研究期间遵守后续检查。

排除标准：

  1. 怀孕、哺乳或打算在研究期间怀孕的女性。

    注意：怀孕或哺乳的女性可能要到分娩后 6 个月或已停止哺乳并且有屈光稳定性记录后才能入组。

  2. 同时使用可能损害愈合的全身（包括吸入）药物，包括但不限于：治疗后 6 个月内的抗代谢药、异维甲酸 (Accutane®) 和治疗后 12 个月内的胺碘酮盐酸盐 (Cordarone®)。 注意：在过去 6 个月内使用吸入性或全身性皮质类固醇，无论是慢性还是急性，都被认为对愈合产生不利影响，使用此类药物的受试者被明确排除在资格之外。

  3. 有以下任何一种病史，或任何其他可能影响伤口愈合的病症：胶原血管病、自身免疫性疾病、免疫缺陷病、眼部带状疱疹或单纯疱疹、内分泌失调（包括但不限于不稳定的甲状腺疾病和糖尿病） )、狼疮和类风湿性关节炎。

    注：无论疾病持续时间、严重程度或控制如何，糖尿病（1 型或 2 型）的存在都将明确排除受试者的资格。

  4. 装有心脏起搏器、植入式除颤器或其他植入式电子设备的受试者。

  5. 既往眼内或角膜手术史（包括白内障摘除术）、活动性眼科疾病或异常（包括但不限于症状性睑缘炎、复发性角膜糜烂、干眼症、距角膜缘 > 1 毫米的新血管形成）、视网膜脱离/修复、具有临床意义的晶状体混浊、外伤的临床证据、角膜中央 9 毫米内的混浊并且在地形图上可见、既往有斜视手术史、斜视或有发生斜视的风险，或有青光眼或窄角型青光眼倾向或疑似青光眼的证据。

    注意：患有青光眼的受试者，无论药物治疗方案或控制如何，或筛查时 IOP 大于 21 mmHg，都被明确排除在资格之外。

  6. 圆锥角膜、角膜营养不良或不规则或地形异常的证据。
  7. 已知对术后过程中使用的任何药物敏感或反应不当。
  8. 基于对隐形眼镜试验的问卷调查回答对单视矫正的不耐受（请参阅下面的研究程序，隐形眼镜试验部分）。
  9. 同时参加任何其他临床试验，或最近 14 天内参加任何其他临床试验。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：波前引导 Lasik Monovision 治疗
使用带有 iDesign Refractive Studio 的 STAR S4 IR® 准分子激光系统对患有老花眼的近视受试者进行波前引导 LASIK 单视治疗。
设备：配备 STAR S4 IR® 准分子激光系统的 iDesign Refractive Studio
外科医生将根据使用 iDesign Refractive Studio 获得的测量结果执行波前引导单视 LASIK 治疗老花眼近视受试者。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Driving Scale Score From Preoperative to Postoperative as Measured by Driving Scale Within Patient-Reported Outcomes With LASIK for Monovision (PROWL-M)
大体时间：From preoperative (within 120 to 14 days prior to surgery on Day 0) to 12 month postoperative (operated on Day 0)
Change in driving scale score from preoperative to postoperative as measured by driving scale within PROWL-M was reported. PROWL-M driving scale consists of three driving related items that were used to generate the driving scale score. Each item response was converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 (not functioning) and 100 (functioning) points. A high score represents better functioning. The composite driving scale score was calculated by averaging the scores of all the three items, resulting in a total score ranging from 0 to 100 where higher score represent better functioning. Change in driving scale score was defined as the driving scale score at 12-month visit minus the driving scale score at preoperative visit.
From preoperative (within 120 to 14 days prior to surgery on Day 0) to 12 month postoperative (operated on Day 0)
Percentage of Participants Who Required Secondary Surgery to Reverse Monovision
大体时间：At 12 month postoperative (operated on Day 0)
Percentage of participants who required secondary surgery to reverse monovision was reported.
At 12 month postoperative (operated on Day 0)

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Who Experienced Bothersome Visual Symptom (Double Image) as Assessed by PROWL-M: In Last 7 Days, How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (double image) as assessed by PROWL-M (in Last 7 Days, how bothersome have the symptoms been when wearing the best vision correction [glasses or contact lenses]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In last 7 days how bothersome have the double images symptoms been when wearing the best vision correction" of double images was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Double Image) as Assessed by PROWL-M: In Last 7 Days, How Bothersome Have the Symptoms Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (double image) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction [glasses or contact lenses]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the double images been symptoms been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Glare) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (glare) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction [glasses or contact lenses]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the glare been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Glare) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (glare) as assessed by PROWL-M questionnaire was reported. The PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction [glasses or contact lenses]) was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the glare been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Halo) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (halo) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction [glasses or contact lenses]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the Halos been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Halo) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (halo) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when not wearing any vision correction [glasses or contact lenses]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the halos been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Starbursts) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptoms Been When Wearing the Best Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (starbursts) as assessed by PROWL-M questionnaire (in last 7 days, how bothersome have the symptoms been when wearing the best vision correction [glasses or contact lenses]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the starbursts been when wearing the best vision correction (glasses or contact lenses)" was categorize as: (1) participant do not use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Bothersome Visual Symptom (Starbursts) as Assessed by PROWL-M: In the Last 7 Days How Bothersome Have the Symptom Been When Not Wearing Any Vision Correction (Glasses or Contact Lenses)?
大体时间：3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of participants who experienced bothersome visual symptom (starbursts) as assessed by PROWL-M questionnaire (in Last 7 Days, how bothersome have the symptoms been when not wearing any vision correction [glasses or contact lenses]) was reported. The PROWL-M questionnaire was designed to measure visual symptoms, patient satisfaction, and expectations for and following LASIK surgery. The response for question "In the last 7 days how bothersome have the starbursts been when not wearing any vision correction (glasses or contact lenses)" was categorize as: (1) participant always use glasses or contact lenses, (2) extremely bothersome, (3) very bothersome, (4) somewhat bothersome, (5) a little bothersome, (6) not at all bothersome.
3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Moderate to Severe Difficulty in Activities
大体时间：Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of participants who experienced moderate to severe difficulty in activities was reported. Participants were asked questions about the difficulty they faced with daily activities, work or hobbies, reading, and judging distances. Responses was collected in 6 categories: (1) No difficulty at all, (2) A little difficulty, (3) moderate difficulty, (4) a lot of difficulty, (5) never try to do these activities because of vision, (6) Never do these activities for other reasons. Categories with non-zero data values are reported.
Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Experienced Satisfaction With Vision as Measured by PROWL-M Questionnaire
大体时间：Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of participants who experienced satisfaction with vision was reported. Satisfaction with vision was assessed using a single-item question in the PROWL-M questionnaire. Participants were asked a question "In general, how satisfied or dissatisfied are you with your present vision". Responses was collected in 6 categories: (1) completely satisfied, (2) very satisfied, (3) somewhat satisfied, (4) somewhat dissatisfied, (5) very dissatisfied, (6) completely dissatisfied. Categories with non-zero data values are reported.
Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Subject Satisfaction Score With Surgery as Measured by PROWL-M Questionnaire
大体时间：3 months, 6 months, and 12 months postoperative (operated on Day 0)
A questionnaire derived from the PROWL-M was given to participants after surgery. Satisfaction with LASIK via PROWL-M questionnaire was assessed with 8 items. Responses to individual items were linearly transformed to a 0 to 100 scale where 100 indicates best possible vision and satisfaction, while 0 indicates worst possible vision and satisfaction. Each item score was averaged together to produce a score ranging from 0 to 100. A higher score indicating greater satisfaction.
3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of Participants Who Achieved 20/40 Or Better Simultaneous Binocular Uncorrected Visual Acuity (UCVA)
大体时间：Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)
Percentage of participants who achieved 20/40 or better simultaneous binocular UCVA measured using Good-Lite 100 percent (%) proportionally spaced SLOAN letter/ETDRS charts designed for 4.0 meter (m) and the Good-Lite self-illuminated and self-calibrated illumination box were reported.
Preoperative (within 120 to 14 days prior to surgery on Day 0), 3 months, 6 months, and 12 months postoperative (operated on Day 0)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AMO Development, LLC

调查人员

  • 研究主任：AMO Development, LLC Clinical Trial、AMO Development, LLC

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年9月24日

初级完成 (实际的)

2025年6月25日

研究完成 (实际的)

2025年6月25日

研究注册日期

首次提交

2019年8月29日

首先提交符合 QC 标准的

2019年8月29日

首次发布 (实际的)

2019年8月30日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年6月25日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • STAR-122-MVPM

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

强生医疗器械公司与耶鲁大学开放数据访问 (YODA) 项目达成协议，作为独立审查小组评估研究人员和医生对临床研究报告和参与者水平数据的请求，以推进医学知识的科学研究和公共卫生。 可以通过 YODA 项目网站 http://yoda.yale.edu 提交访问研究数据的请求。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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