Evaluation of Refractive Outcomes in Patients Undergoing PRESBYOND Using the MEL90 Excimer Laser
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better
研究概览
简要总结
The goal of this clinical trial is to collect information on vision outcomes in people aged 45 to 65 who have difficulty seeing clearly at near distances due to aging (a condition called presbyopia). All participants will receive the same treatment: laser eye surgery with the PRESBYOND method using the MEL 90 excimer laser.
The main questions this study aims to answer are:
- How well do patients see at distance, intermediate, and near after treatment?
- How satisfied are patients with their vision after surgery?
Participants will:
- Attend seven visits over six months (before surgery and after surgery at 1 day, 1 week, 1 month, 3 months, and 6 months)
- Undergo laser eye surgery with PRESBYOND
- Complete vision tests and questionnaires about their experience
There is no comparison group in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 45 and 65 years old
- •Scheduled to undergo bilateral LASIK treatment with PRESBYOND
- •Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye
- •Normal corneal topography in each eye
- •Discontinue use of contact lenses at least 1 month for hard contacts and 1 week for soft lenses prior to the preoperative examination
- •Residual stromal thickness ≥250 microns in each eye
- •Availability, willingness, to comply with examination follow up visits
- •Signed informed consent and data protection documents
- •Patients successfully passed the tolerance test
排除标准
- •Mixed astigmatism in any eye
- •Irregular corneal astigmatism in any eye
- •Clinically significant ocular surface disease in any eye
- •History of ocular surgery, ocular pathology, or other significant ocular findings that, in the Investigator's opinion, may increase the patient's risk for corneal refractive surgery or affect potential visual outcomes in each eye
- •Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye
- •Amblyopia, strabismus, nystagmus, forme fruste keratoconus in any eye
- •Clinically significant pupil abnormalities in any eye
- •Use of systemic or ocular medications that may affect visual outcomes
- •Systemic pathology that may affect the results of the study
- •Pregnancy or being treated for conditions associated with hormonal fluctuation
- •Participation in another clinical trial in the last 30 days
结局指标
主要结局
Proportion of patients achieving binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better
时间窗: 6 months after surgery
The primary endpoint of the study is the proportion of patients achieving a binocular uncorrected near visual acuity (UNVA) of 0.1 logMAR or better at 6 months postoperatively. Near visual acuity is assessed using standardized near vision charts under controlled lighting conditions, following standard clinical protocols. Measurements are taken binocularly to reflect functional vision in daily life.
次要结局
未报告次要终点