有和没有囊袋张力环的复曲面人工晶状体旋转：来自一项多中心非劣效性随机临床试验（RCT）的数据。
Rotation of a toric intraocular lens with and without capsular tension ring: data from a multicenter non-inferiority randomized clinical trial (RCT).
作者信息
Hahn Ursula, Krummenauer Frank, Schmickler Stefanie, Koch Jörg
机构信息
Institute for Medical Biometry and Epidemiology, Witten/Herdecke University, Faculty of Health, Alfred-Herrhausen.Straße 50, 58448, Witten, Germany.
OcuNet Trial Alliance, Duesseldorf, Friedrichstraße 47, 40217, Duesseldorf, Germany.
出版信息
BMC Ophthalmol. 2019 Jul 8;19(1):143. doi: 10.1186/s12886-019-1147-5.
BACKGROUND
Evaluation of clinical outcome in cohorts with versus without simultaneous implantation of a capsular tension ring (CTR) and a toric lens (Tecnis Toric). Main parameter was rotation referring - in contrast to misalignment - to the IOL axis change from immediately after implantation to the final postoperative position.
METHODS
Lens position was measured at baseline with the patient still in recumbent position, postoperative rotation was calculated by software. Postoperative evaluation included measurement three months after surgery or prior to an indicated revision surgery. Explorative re-evaluation of the underlying RCT's intent-to-treat population was performed for the entire sample and stratified for cohorts by 95% confidence intervals for binary endpoints' incidences (primary endpoint: absolute postoperative rotation ≤5 degrees; secondary endpoints: absolute deviation between achieved cylinder and target cylinder ≤0.5 dpt, postoperative corrected distance visual acuity (CDVA) ≥ 0.8). Data exploration was based on medians and quartiles.
SETTING
Outpatient study sites.
DESIGN
Re-evaluation based on data from a multicenter non-inferiority randomized clinical trial (RCT).
RESULTS
Sub cohorts (without CTR 89, with CTR 90 patients) did not present clinically relevant differences in preoperative characteristics: revision surgery was performed in 7 cases (3 without and 4 with CTR). Primary endpoint incidences for the total sample, without and with CTR were 90%/89%/90%; cylinder endpoint incidences were 46%/45%/46% and CDVA endpoint incidences 90%/92%/88%. Median absolute rotations were 1.74°/1.79°/1.72°, median absolute cylinder deviations 0.55/0.52/0.55 dpt and median visual acuity 1.0/1.0/1.0.
CONCLUSION
No clinically relevant differences between CTR subgroups were found; a satisfying three months rotational stability was achieved.
TRIAL REGISTRATION
The trial was registered retrospectively in the trial registry DRKS, trial registration number DRKS00015316 , date of registration 27. August 2018.
背景
评估同时植入囊袋张力环（CTR）和散光人工晶状体（Tecnis Toric）与未植入的队列的临床结局。主要参数是旋转，与偏心不同，旋转是指人工晶状体轴从植入后即刻到术后最终位置的变化。
方法
在基线时患者仍处于卧位状态下测量晶状体位置，术后旋转由软件计算得出。术后评估包括术后三个月或在进行指定的翻修手术前进行测量。对整个样本进行了探索性重新评估，该样本来自一项随机对照试验（RCT）的意向性治疗人群，并按队列分层，计算二元终点发生率的95%置信区间（主要终点：术后绝对旋转≤5度；次要终点：达到的柱镜度数与目标柱镜度数之间的绝对偏差≤0.5 dpt，术后矫正远视力（CDVA）≥0.8）。数据探索基于中位数和四分位数。
地点
门诊研究地点。
设计
基于多中心非劣效性随机临床试验（RCT）的数据进行重新评估。
结果
亚组（未植入CTR的89例患者，植入CTR的90例患者）术前特征无临床相关差异：7例患者进行了翻修手术（3例未植入CTR，4例植入CTR）。整个样本、未植入CTR组和植入CTR组的主要终点发生率分别为90%/89%/90%；柱镜度数终点发生率分别为46%/45%/46%，CDVA终点发生率分别为90%/92%/88%。绝对旋转中位数分别为1.74°/1.79°/1.72°，绝对柱镜度数偏差中位数分别为0.55/0.52/0.55 dpt，视力中位数分别为1.0/1.0/1.0。
结论
未发现CTR亚组之间存在临床相关差异；术后三个月实现了令人满意的旋转稳定性。
试验注册
该试验在试验注册机构DRKS进行了回顾性注册，试验注册号为DRKS00015316，注册日期为2018年8月27日。
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