A Prospective, Multi-centre, Single-Arm Clinical Trial of Orthokeratology Lenses (MCOK-01) in Subjects With Myopia and Myopic Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 8
- 主要终点
- Proportion of eyes achieved uncorrected distance visual acuity of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR
研究概览
简要总结
This is a prospective, multi-centre, single-arm clinical trial to evaluate the effectiveness and safety of MCOK-01 lenses in patients with myopia and myopic astigmatism who need dioptric correction.
A maximum number of 220 participants are planned to be enrolled , with a minimum of 150 planned to complete the trial (30% dropout). All participants will be enrolled in Australia.
Enrolled participants will wear the lenses every night for up to 12 months, removing them upon waking. 8 follow up visits will be completed during treatment, after: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months of wearing the lenses.
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
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant diagnosed with myopia and myopic astigmatism, documented by an eye care practitioner.
- •Participant is between 6-40 years old inclusive.
- •Participant is not motivated to wear glasses in daily life.
- •Participants are of Caucasian ethnicity (must be >50% of study population) or other non-east Asian ethnic groups (Indian, Sri-Lankan, Pakistani, etc). Neither parent of participant can be east-asian.
- •Provision of written informed consent.
- •Participants understand and agree to all requirements of the clinical trial; visit schedule, investigator guidance, follow-lens instructions, etc
排除标准
- •Best corrected distance vision acuity of less than 0.8 with spectacles.
- •Subjective refraction test shows spherical power greater than -6.00D,less than -0.50D or astigmatism greater than 1.5D.
- •Participants of East-Asian ethnicity (Chinese, Japanese, Korean, etc).
- •Participants requiring treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses).
- •Medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc)..
- •Medical history of refractive corneal surgery.
- •Slit lamp findings that are more serious than grade 1
- •Participants requiring lens parameters outside of the scope of lens for this clinical trial.
- •Known eye allergies or conditions that are contraindicated, including sensitivity to any lens care maintenance or packaging solution additives being used in this study
- •Corneal abnormalities including keratoconus, corneal dystrophy and/or previous history of ocular herpes infections.
- •Currently using Atropine, or have used Atropine eye drops 14 days prior to enrolment.
- •For female participants, pregnancy, planned pregnancy during the trial or breastfeeding (pregnancy status provided by verbal confirmation).
- •Participation in other clinical trials or participation within the past 30 days.
- •Use of orthokeratology lenses within the prior 90 days, extended wear, rigid gas permeable corneal and scleral lenses within the prior 30 days, daily disposable and daily wear within the prior 15 days.
- •Mental incapacity.
- •Other Participants deemed not suitable for the trial at the investigator's discretion
结局指标
主要结局
Proportion of eyes achieved uncorrected distance visual acuity of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR
时间窗: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Measured using a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
Lines of improvement of monocular uncorrected distance visual acuity
时间窗: 12-months following enrolment
Reading of a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
A level of attempted versus achieved reduction in manifest refractive error
时间窗: 12 months following enrolment
Using a Phoropter/Refractor. Proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano)
Number and rates (by type of event and relation to device) of serious and significant adverse events
时间窗: Any time within the 12-months enrolment window
Adverse events will be self-reported by participants to investigative team
Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events.
时间窗: Any time within the 12-months enrolment window
Adverse events will be self-reported by participants to investigative team
Number of slit lamp results above grade 2
时间窗: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Assessed using a slit lamp
Number and rate of cases of loss of; monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar).
时间窗: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Assessed with a logMAR chart
Proportion of eyes achieved uncorrected distance visual acuity of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR
时间窗: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Measured using a logMAR chart. Each line difference represents 0.1 logMAR acuity. The improvement in acuity is represented by a numerical reduction in the logMAR value.
A level of attempted versus achieved reduction in manifest refractive error
时间窗: 12 months following enrolment
Using a Phoropter/Refractor. Proportion of eyes with manifest sphere within ±0.50 D, ±1.00 D, and ±2.00 D of the target (plano)
Number and rates (by type of event and relation to device) of serious and significant adverse events
时间窗: Any time within the 12-months enrolment window
Adverse events will be self-reported by participants to investigative team
Number and rate of cases of loss of; monocular best spectacle corrected visual acuity (BSCVA) of 2 or more lines (≥ 0.2 logMar), and 1 or more lines (≥ 0.1 logMar).
时间窗: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment
Assessed with a logMAR chart
次要结局
- Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline(6 months and 12 months following enrolment)
- Descriptive statistics of central corneal thickness(6 months, and 12 months following enrolment)
- Frequency and reasons for lens replacement(Any time within the 12-months enrolment window)
- Stability in manifest refractive error(1 month and 3 months following enrolment)
- Stability in unaided visual acuity(1 month and 3 months following enrolment)
- Improvement of monocular uncorrected distance visual acuity(1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Change in best corrected spectacle visual acuity(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Changes in manifest sphere(1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Corneal topography changes(12 months following enrolment)
- Number and rates of average wear time per day(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Damage or scratches on the lenses(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- A level of attempted versus achieved reduction in manifest refractive error(1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Number of discontinued participants and the reasons for discontinuation(Any time within the 12-months enrolment window)
- Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment(12 months following enrolment)
- Change in absolute corneal astigmatism(12 months following enrolment)
- Signs/symptoms and complications from subjective questionnaires(1 month, 6 months, and 12 months following enrolment)
- Descriptive statistics of specular microscopy measurements(12 months following enrolment)
- Change in best corrected spectacle visual acuity(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Changes in manifest sphere(1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Stability in unaided visual acuity(1 month and 3 months following enrolment)
- Improvement of monocular uncorrected distance visual acuity(1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- A level of attempted versus achieved reduction in manifest refractive error(1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Corneal topography changes(12 months following enrolment)
- Change in absolute corneal astigmatism(12 months following enrolment)
- Number of discontinued participants and the reasons for discontinuation(Any time within the 12-months enrolment window)
- Number and rates of average wear time per day(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Increase in corneal or refractive astigmatism of 2D or more and 1D or more post-treatment(12 months following enrolment)
- Signs/symptoms and complications from subjective questionnaires(1 month, 6 months, and 12 months following enrolment)
- Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline(6 months and 12 months following enrolment)
- Descriptive statistics of specular microscopy measurements(12 months following enrolment)
- Descriptive statistics of central corneal thickness(6 months, and 12 months following enrolment)
- Frequency and reasons for lens replacement(Any time within the 12-months enrolment window)
- Damage or scratches on the lenses(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment)
- Stability in manifest refractive error(1 month and 3 months following enrolment)