Assessment of Clinical and Refractive Outcomes of the Use of a Femtosecond to Treat the Symptoms of Presbyopia in a Patient With Implanted Mono Focal IOLs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Distance corrected near visual acuity (DCNVA) at 40 cm
研究概览
简要总结
This study aimed to assess the safety and efficacy of treating presbyopia in eyes implanted with a mono focal IOL using a low-energy femtosecond laser.
详细描述
An investigative device built by Perfect Lens was used to adjust an implanted IOL in 38 eyes.
The device uses a femtosecond laser, a scanner, and an OCT. Each patient was presbyopic pre-treatment. The primary endpoint for the treatment was to create near vision in the treated eye without sacrificing the existing far vision. The first patient was treated in October 2023 and the last patient was treated in July 2024. The last patient visit was in November 2024.
The patients were examined at 7 days, 30 days and 90 days after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand study requirements, follow study instructions and to return for required study follow-up visits as confirmed by provision of written informed consent;
- •Subject has undergone cataract surgery and has had a monofocal lens implanted in both eyes;
- •Subject has no significant residual visual issues which the Investigator believes would make the patient ill suited for the Treatment.; and
- •Both eyes have CDVA vision of 20/25 or better at 4m.
排除标准
- •Subjects not able to complete the informed consent form;
- •Clinically significant corneal abnormalities including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), inflammation, keratitis, keratoconjunctivitis, keratouveitis, keratopathy, keratectasia or edema per the Investigator's expert medical opinion;
- •Previous corneal surgery;
- •Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the subjects' participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
- •History of or current retinal conditions or predisposition to retinal conditions including retinal detachment, diabetic retinopathy, age related macular degeneration which are assessed to by investigator to confound outcomes;
- •History of or current anterior or posterior segment inflammation of any etiology, or any disease-producing an inflammatory reaction in the eye (e.g., iritis or uveitis);
- •Optic nerve atrophy;
- •Iris neovascularization;
- •Subjects with diagnosed degenerative eye disorders (e.g., macular degeneration or other retinal disorders);
- •Uncontrolled glaucoma;
- •Any subject currently participating in another investigational drug or device studies; and
- •Any subject disqualified by the Principal Investigator or Medical Monitor for any ocular issue.
研究组 & 干预措施
Application of Perfector laser treatment
Active treatment arm
干预措施: Perfector (Device)
结局指标
主要结局
Distance corrected near visual acuity (DCNVA) at 40 cm
时间窗: 1 month after treatment
Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 40 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. The hypothesis tested for is to demonstrate superiority of the near vision of treated IOL to the IOL pre-treatment.
Distance corrected intermediate visual acuity (DCIVA) at 66 cm
时间窗: 1 month after treatment
Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 66 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. The hypothesis tested for is to demonstrate non-inferiority of the treated IOL to the pre-treated IOL (using a non-inferiority margin of 0.10 logMAR).
Corrected distance visual acuity (CDVA) at 4 m
时间窗: 1 month after treatment
Visual acuity (VA) was tested monocularly and binocularly (both eyes together) using the manifest refraction adjusted for infinity and stand Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 4 meters (m) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. The hypothesis tested for the co-primary effectiveness endpoint is to demonstrate non-inferiority of the treated IOL to the pre-treatment IOL (using a non-inferiority margin of 0.10 logMAR).
次要结局
- Uncorrected distance visual acuity (UDVA)(1 week, 1month and 3 months after treatment)
- Uncorrected intermediate visual acuity at 66 cm (UIVA)(1 week, 1month and 3 months after treatment)
- Uncorrected near visual acuity at 40 cm (UNVA)(1 week, 1month and 3 months after treatment)
- Corrected near visual acuity at 40 cm (CNVA)(1 week, 1month and 3 months after treatment)
- Defocus curve(1month and 3 months after treatment)
- Contrast sensitivity(3 months after treatment)
- Subjective refraction(1 week, 1month and 3 months after treatment)
- Near addition(1 week, 1 month and 3 months after treatment)
- Slit Lamp examination findings(1 week, 1month and 3 months after treatment)
- Fundus examination findings(1 week, 1month and 3 months after treatment)
- Intraocular pressure(1 week, 1month and 3 months after treatment)
- Spectacle independence questionnaire(3 months after treatment)
- QoV patient questionnaire(3 months after treatment)
- Adverse Events(1 week, 1month and 3 months after treatment)
- Device deficiency(1 week, 1 month and 3 months after treatment)