A comparative analysis of the intraoperative and preoperative time flow between visumax 800 vs visumax 500
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
IntroductionSmall incision lenticule extraction (SMILE) and other femtosecond laser assisted keratorefractive procedures are well established options for the correction of myopia and myopic astigmatism, with high efficacy, safety, and predictability across large clinical series. Over the past decade, device evolution from the first generation VISUMAX 500 (500 kHz) to the second generation VISUMAX 800 (2 MHz) has focused not only on visual outcomes but also on workflow efficiency, with the newer platform designed to shorten laser time, docking time, and overall procedural duration.
The VISUMAX 800 features a higher pulse repetition rate and upgraded scanning system that allow refractive lenticule creation in less than 10 to 11 seconds compared with approximately 25 to 30 seconds on the VISUMAX 500, and can reduce total surgical time by approximately 1.5 to 2 minutes per case without compromising visual results. Recent comparative studies have demonstrated significantly shorter docking time, laser time, and overall surgical time with the VISUMAX 800 while maintaining similar refractive accuracy, safety indices, higher order aberrations, and contrast sensitivity when compared with the VISUMAX 500.
Beyond intraoperative timing, the cumulative time from preoperative assessment to completion of surgery including diagnostics, counseling, preparation, laser treatment, and immediate postoperative evaluation directly influences operating room throughput, staff utilization, and patient experience in high volume refractive centers.
Although published data confirm intraoperative time savings with the VISUMAX 800, there is limited evidence quantifying how this translates into overall perioperative time flow across the entire patient pathway when compared with the VISUMAX 500.
A structured evaluation of time flow from preoperative assessment to completion of surgery for VISUMAX 800 versus VISUMAX 500 can therefore provide critical information for service planning, scheduling, and resource allocation in refractive surgery units. By mapping and comparing time points at key steps such as preoperative diagnostics, slit lamp evaluation, consent and counseling, surgical preparation, docking, laser delivery, and immediate postoperative checks, this study aims to determine whether the newer platform delivers meaningful gains in overall efficiency without compromising clinical outcomes or patient reported experience.
AimTo evaluate and compare the preoperative and intraoperative time flow between the VISUMAX 500 and the VISUMAX 800.
Material and MethodsThis prospective observational single center study will be approved by the Institutional Ethics Committee of Nethradhama Superspeciality Eye Hospital and will adhere to the tenets of the Declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study.
Preoperative VisitSubjects will provide demographic information and medical history and will undergo the following assessments at the preoperative visit. The time taken to conduct each test will be recorded.
Visual acuity testing Manifest refraction Slit lamp examination Dilated fundus examination Intraocular pressure measurement Corneal topography MS 39 Pupil diameter measurement Anterior segment optical coherence tomography ITrace analysis In patients opting for VISUMAX 800, IOL Master 700 measurement will also be performed
Operative VisitFor patients undergoing SMILE on the VISUMAX 500, preoperative axis marking will be performed on the slit lamp prior to shifting to the operating theater, and the time taken for this step will be recorded.
The time taken by optometrists to evaluate the patient, change into surgical scrubs, and enter patient data into the VISUMAX 500 will be recorded. For the VISUMAX 800, the time taken for remote data transfer will be noted.
Intraoperative time including patient transfer, bed positioning, docking, laser firing, and lenticule dissection will be recorded.
Postoperative Follow UpPostoperative evaluations will be conducted at day 1, 2 weeks, and 3 months after surgery and will include:
Slit lamp examination Measurement of uncorrected and corrected distance visual acuity using ETDRS charts Manifest refraction Objective scatter index and modulation transfer function using HD analyzer
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 diagnosed with Myopic astigmatism Patient topography suitable to undergo Relex Smile Pro.
排除标准
- •Patient with Hypermetropia, presbyopia Borderline Topography High Myopia not suitable for keratorefractive surgery Uncooperative and anxious patients (increases time hence confounding the results) Pupillary Abnormality Any other Ocular Surface Disturbances.
研究者
Dr Supriya Sriganesh
Nethradhama Superspeciality Eye Hospital
