A Clinical Trial Assessing the Safety and Effectiveness of Orthokeratology Lenses in Patients With Myopia and Myopic Astigmatism

Официальное название

A Prospective, Multi-centre, Single-Arm Clinical Trial of Orthokeratology Lenses (MCOK-01) in Subjects With Myopia and Myopic Astigmatism

Обзор

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.

Вмешательства

• Устройство MCOK-01
  The investigational device is a Rigid Gas Permeable contact lenses for orthokeratology. MCOK-01 applied the reverse geometry design and adopted the lens material which possesses the highest oxygen permeability among all the materials for orthokeratology lens.

Первичные конечные точки

• Lines of improvement of monocular uncorrected distance visual acuity [Срок оценки: 12-months following enrolment]
• Proportion of eyes achieved uncorrected distance visual acuity of ≤0.30 logMAR, ≤0.20 logMAR, ≤0.10 logMAR, and ≤0.00 logMAR [Срок оценки: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment]
• A level of attempted versus achieved reduction in manifest refractive error [Срок оценки: 12 months following enrolment]
• Number and rates (by type of event and relation to device) of serious and significant adverse events [Срок оценки: Any time within the 12-months enrolment window]
• Number and rates (by type of event) of all types of adverse events that were not classified as serious or significant adverse events. [Срок оценки: Any time within the 12-months enrolment window]
• Number of slit lamp results above grade 2 [Срок оценки: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment]
• 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). [Срок оценки: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment]

Вторичные конечные точки (12)

• Improvement of monocular uncorrected distance visual acuity [Срок оценки: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment]
• Change in best corrected spectacle visual acuity [Срок оценки: 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment]
• Changes in manifest sphere [Срок оценки: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment]
• A level of attempted versus achieved reduction in manifest refractive error [Срок оценки: 1 month, 3 months, 6 months, 9 months, and 12 months following enrolment]
• Corneal topography changes [Срок оценки: 12 months following enrolment]
• Change in absolute corneal astigmatism [Срок оценки: 12 months following enrolment]
• Number of discontinued participants and the reasons for discontinuation [Срок оценки: Any time within the 12-months enrolment window]
• Number and rates of average wear time per day [Срок оценки: 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 [Срок оценки: 12 months following enrolment]
• Signs/symptoms and complications from subjective questionnaires [Срок оценки: 1 month, 6 months, and 12 months following enrolment]
• Descriptive statistics of intraocular pressure (IOP) and for percent change from baseline [Срок оценки: 6 months and 12 months following enrolment]
• Descriptive statistics of specular microscopy measurements [Срок оценки: 12 months following enrolment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 4 центра

• Eyecare Kids — Hillsdale
• UNSW School of Optometry and Vision Science — Sydney
• Queensland University of Technology Optometry and Vision Science — Kelvin Grove
• The University of Melbourne Department of Optometry and Vision Sciences — Carlton

Идентификаторы

NCT: NCT07047924 · MCOK-3-AUS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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