MULTICENTER, OBSERVATIONAL, SINGLE ARM STUDY OF THE TECNIS PRESBYOPIA-CORRECTING INTRAOCULAR LENS
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- 1. Patient questionnaires for visual symptoms and satisfaction
研究概览
简要总结
The intraocular lenses (IOL) tested in this study, TECNIS PureSee non-toric (model DEN00V) and/or Toric II IOL (models DET100, DET150, DET225, DET300, DET375, DET450, DET525 and DET600), are an EDOF IOL with extended depth of focus that provides good distance vision as well as improved intermediate and near vision compared to a standard monofocal IOL. The study is an observational study of patients’ and surgeons’ experiences with the TECNIS PureSeeâ„¢ IOL. The lack of a control arm is justified as it is a non-comparative evaluation of a CE-marked product with a focus on collecting data on surgeons’ and patients’ experiences with the product.
Post-market data on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PureSeeTM IOL will be collected within the clinical observational study.
Multicenter, single-arm, bilateral clinical observational study. A total of approximately 300 patients will be included, who will be called in once for a prospective postoperative follow-up examination 3 months after bilateral implantation. The preoperative and operative data will be collected retrospectively after inclusion of the patients.
Measures and procedure: After informed consent of the patient and examination of the inclusion and exclusion criteria, each patient will be called in once for a prospective postoperative follow-up examination 3 months (45 -90 days) after surgery of the 2nd eye. During this postoperative visit, visual acuity is measured at distance, intermediate and near. Data on visual symptoms and patient satisfaction are collected. In addition, the binocular measurement of the defocus curve is carried out if necessary. The preliminary examination and the operations on both eyes are not part of the study. The data routinely collected by each study center will be collected retrospectively from the patient’s file after the patient’s consent, and after the single postoperative follow-up examination has been performed for all patients per study center, the surgeons involved per study center will be asked to complete a questionnaire on their experiences with the IOL.
The study will be conducted in EMAE and APAC.
10 EMEA site are included in Germany (2), Netherlands (2), Spain (3), Austria (1), France (2). The study was already approved in all countries included. 4 Sites have been activated, 3 site have started recruitment.
10 APAC sites are planned: Australia (4), Korea (2), India (4)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are bilaterally implanted with TECNIS PureSee IOL following cataract extraction and are at least 45 days postoperative from their second eye surgery at the time of the study visit:.
- •Eyes may be implanted with any combination of TECNIS PureSee non-toric (Model DEN00V) and/or Toric II IOL (Models DET100, DET150, DET225, DET300, DET375, DET450, DET525 and DET600);.
- •Patients with or without prior corneal refractive surgery;.
- •Clear intraocular media;.
- •Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to study procedures in the governing countries;.
- •Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures; • Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided.
排除标准
- •Subjects with ongoing adverse events and/or surgical complications that might impact outcomes during the study visit as determined by the investigator;
- •Use of systemic or ocular medication that may affect vision;
- •Acute or chronic disease or condition, ocular trauma or surgery that may confound results (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus etc.);
- •Patients with amblyopia, strabismus, nystagmus;
- •Concurrent participation in another clinical trial.
结局指标
主要结局
1. Patient questionnaires for visual symptoms and satisfaction
时间窗: 3 months Postoperative after surgery of the 2nd eye
2. Surgeon experience questionnaire
时间窗: 3 months Postoperative after surgery of the 2nd eye
3. Monocular and binocular best-corrected distance visual acuity (BCDVA)
时间窗: 3 months Postoperative after surgery of the 2nd eye
4. Monocular and binocular uncorrected distance visual acuity (UCDVA)
时间窗: 3 months Postoperative after surgery of the 2nd eye
5. Manifest refraction
时间窗: 3 months Postoperative after surgery of the 2nd eye
6. Binocular uncorrected and distance-corrected intermediate visual acuity (UCIVA & DCIVA) at 66 cm
时间窗: 3 months Postoperative after surgery of the 2nd eye
次要结局
- 1. Visual Symptoms(2. Surgeon Experience)
研究者
Dr Namrata Sharma
All India Institute of Medical Sciences (AIIMS)