Comparison of PRESBYOND Laser Blended Vision and Conventional Monovision LASIK in Individuals With Presbyopia: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving target binocular visual acuity at multiple distances
研究概览
简要总结
The goal of this clinical trial is to learn if laser blended vision (LBV) works better than traditional monovision LASIK to correct presbyopia in adults aged 40 to 55 years. Presbyopia is an age-related condition that makes it hard to see things up close. The study will also evaluate the safety of both procedures.
The main questions it aims to answer are:
Does LBV improve distance, intermediate, and near vision at the same time after surgery? Is LBV as safe as traditional monovision LASIK?
Researchers will compare laser blended vision to traditional monovision LASIK to see if LBV provides better overall vision after surgery.
Participants will:
Be randomly assigned to receive either laser blended vision or traditional monovision LASIK Have standard eye examinations before surgery Undergo LASIK surgery using the assigned method Return for follow-up visits at 1 week, 1 month, 3 months, and 6 months after surgery Complete vision tests and questionnaires about visual quality and satisfaction
详细描述
Presbyopia is an age-related condition that causes difficulty seeing at near distance and often leads to visual fatigue and dependence on reading glasses. Corneal refractive surgery has become an option for presbyopia correction. Traditional monovision LASIK corrects one eye for distance and the other eye for near vision, but some people may experience reduced depth perception or visual discomfort. Laser blended vision (LBV) is a modified LASIK technique designed to increase depth of focus and improve vision at multiple distances while maintaining binocular visual function. However, high-quality randomized clinical trials comparing LBV with traditional monovision LASIK are limited.
The purpose of this study is to compare the visual outcomes and safety of laser blended vision and traditional monovision LASIK in adults with presbyopia.
This study is a single-center, randomized, parallel-group clinical trial. About 100 participants aged 40 to 55 years who are suitable for LASIK surgery will be enrolled. Participants will be randomly assigned in a one-to-one ratio to receive either laser blended vision or traditional monovision LASIK.
All surgeries will be performed using standard LASIK procedures by experienced surgeons. Participants will undergo routine eye examinations before surgery and will be followed after surgery at scheduled visits, including 1 week, 1 month, 3 months, and 6 months.
The main evaluation will assess whether participants achieve good uncorrected distance, intermediate, and near vision at 6 months after surgery. Additional assessments will include refractive accuracy, visual quality, stereopsis, contrast sensitivity, patient-reported visual function, and safety outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 to 55 years with presbyopia
- •Suitable candidates for LASIK surgery based on clinical evaluation
- •Stable refractive status for at least 1 year
- •Best corrected distance visual acuity within normal range
- •Willing and able to provide written informed consent
- •Willing to comply with study visits and follow-up
排除标准
- •Previous ocular surgery
- •Corneal disease or abnormal corneal condition that may affect safety
- •Significant ocular disease affecting visual function
- •Severe dry eye or other ocular surface disorders
- •Systemic disease that may affect study participation
- •Inability to tolerate monovision or anisometropia
- •Any condition that the investigator considers unsuitable for the study
研究组 & 干预措施
Traditional Monovision LASIK
Participants will receive standard monovision LASIK for presbyopia correction, with the dominant eye corrected for distance and the non-dominant eye targeted for mild myopia to improve near vision.
干预措施: Traditional Monovision LASIK (Procedure)
Laser Blended Vision LASIK
Participants will undergo laser blended vision LASIK. The dominant eye will be corrected for distance vision, and the non-dominant eye will be targeted for mild myopia to improve near vision using a laser blended vision design.
干预措施: Laser Blended Vision LASIK (Procedure)
结局指标
主要结局
Proportion of participants achieving target binocular visual acuity at multiple distances
时间窗: 6 months after surgery
Proportion of participants who achieve binocular uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA) of 0.8 (logMAR 0.10) or better.
次要结局
- Binocular uncorrected visual acuity(1 week, 1 month, 3 months, and 6 months after surgery)
- Refractive accuracy after surgery(1 week, 1 month, 3 months, and 6 months after surgery)
- Refractive stability over time(Up to 6 months after surgery)
- Contrast sensitivity(1 week, 1 month, 3 months, and 6 months after surgery)
- Stereoacuity(1 week, 1 month, 3 months, and 6 months after surgery)
- NEI Visual Function Questionnaire-25 (NEI VFQ-25)(1 week, 1 month, 3 months, and 6 months after surgery)
- Quality of Vision (QoV) questionnaire(1 month, 3 months, and 6 months after surgery)
- Spectacle independence(1 month, 3 months, and 6 months after surgery)
- Visual safety outcomes(1 week, 1 month, 3 months, and 6 months after surgery)
- Postoperative complications(From surgery to 6 months after surgery)