Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UMC Utrecht
- 入组人数
- 94
- 试验地点
- 6
- 主要终点
- Cost-effectiveness
研究概览
简要总结
Background of the study:
Cataract is widely prevalent in especially elderly and cataract extraction surgery has thus become one of the most performedsurgeries worldwide. In recent decades the safety of cataract surgery has greatly improved and it is considered one of the safestsurgeries to be performed. Postoperative management consists of routine examinations within one week, to ascertain no adverseevents have occurred immediately after surgery, and between 4-6 weeks, to determine the refractive error. The incidence of seriousadverse events following cataract surgery is estimated to be 1%. As a result, the majority of patient visits after cataract surgery willbe uneventful. Nonetheless valuable time and hospital resources are consumed. Remote monitoring could replace clinicalexaminations in selected patient groups. However, this practice of digital remote monitoring which the patient can use independentlyhas not been clinically validated yet.
Objective of the study:
To determine non-inferiority of the corrected distance visual acuity (CDVA) with the prescription obtained through the web-basedmeasurement of refractive error, compared to usual care, in patients who underwent routine cataract surgery.
Study design:
Observational randomized trial without interventions
Study population:
Patients eligible for cataract surgery, without visual acuity influencing comorbidities or predisposing complicating factors.
Primary study parameters/outcome of the study:
costeffectiveness
Secundary study parameters/outcome of the study (if applicable):
Corrected distance visual acuity at the final post-operative visit, uncorrected distance visual acuity, refractive error(sphere/cylinder/axes), patient reported outcome measurements, adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned for bilateral phacoemulsification cataract extraction and intra-ocular lens implantation (either sequentialor in one procedure)
- •≥ 18 years of age
- •No other current ophthalmic conditions or history that negatively influence post-operative visual acuity
- •Be able to fill out the health questionnaires (in Dutch, German or English) and perform the web-based refractiveassessment (possibly with assistance of family member or other close relative).
- •Specific digital requirements include access to a computer and a smartphone and knowledge how to log in to anonline patient portal.
排除标准
- •Cataract extraction surgery combined with other procedures, including: keratoplasty, vitrectomy, glaucoma filter implants
- •Ocular comorbidities that negatively influence post-operative visual acuity
- •No access to the digital requirements to take the online health questionnaire and/or perform the online refraction.
- •Insufficient command of the Dutch, German or English language to understand the questionnaires andinstructions of the web-based refractive assessment or no family member / close relative to assist with this
- •Inability of performing the web-based eye exam prior to cataract surgery.
研究组 & 干预措施
Telemonitoring
Subjects in the telemonitoring group will have post-operative follow-up measurements involving teleconsultations, remote eye exams and health questionnaires.
干预措施: remote monitoring after cataract surgery (Other)
Usual care
Subjects in the usual care group will receive regular post-operative care, mostly involving in-hospital consultations.
结局指标
主要结局
Cost-effectiveness
时间窗: pre-operative until 3 months after surgery
The main outcome measure will be Incremental cost-effectiveness ratio (ICER), defined as euros per QALY, and compared between the two groups.
次要结局
- Patient reported outcomes(pre-operative vs 3 months after surgery)
- Corrected distance visual acuity at the final post-operative visit (achieved with web-based vs manifest refraction)(4-6 weeks after surgery)
- Uncorrected distance visual acuity (web-based vs reference chart)(pre-operative, 4-6 weeks after surgery)
- Total costs(pre-operative until 3 months after surgery)
- Adverse events / additional consultations(pre-operative until 3 months after surgery)
- QALY's(pre-operative and 3 months after surgery)
- Refractive error in sphere/cylinder/axes (web-based vs reference chart)(4-6 weeks after surgery)
研究者
Robert P.L. Wisse, MD PhD
Principal Investigator
UMC Utrecht