Contact Lens Aftercare Refinement Initiative for Frequency Intervals
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Safe and effective lens wear for first 1 year of contact lens wear
研究概览
简要总结
Patients who want to wear contact lenses often need to visit the optician multiple times. For example, they might go for an eye test, then return for the contact lens fitting, come back to pick up the lenses, and then again for follow-up care and check-ups. Right now, there are no clear guidelines on how many visits are needed for efficient and high-quality contact lens care.
The purpose of the current study is to understand the scheduling and frequency of follow-up visits required for both new contact lens wearers and those who are experienced.
详细描述
Overview / Background / unmet need:
Soft contact lens technology and contact lens related clinical practice have evolved significantly over the last three decades[1] . Improvements have been made in every direction: significant improvement in material biocompatibility and transmissibility, enhanced lens designs and optics, wider power ranges, better care regimes, and almost all possible and flexible modalities of lens wear and replacement frequencies. Similarly, eye care professionals (ECPs) are also directed by UK clinical practice guidelines detailed by professional bodies which are aimed at maintaining high levels of ocular health and providing satisfactory vision and comfort [2].
However, current approach for soft contact lens fitting and subsequent follow up appointments, which is defined in the UK by the number of patient visits required to satisfy a new contact lens fit[3], proceeded by follow-up visits to continue safe and healthy lens wear have remained largely conservative[3] . The general course of action has not evolved over recent decades where patients are recalled several times during their journey of contact lens fit in the first few months of wear, likely due to potential complications and challenges faced by the earlier lens materials, designs and limited replacement frequencies [4] and habits formed by ECPs over the years. Although current contact lens materials are superior for benefits such as oxygen performance, wettability and deposition, a variety of wearing modalities and replacement frequencies are available, along with a wide range of powers such that virtually all potential wearers can be fitted with contact lenses. With the advent of a range of virtual assessment tools, contact lens aftercare and frequency of routine clinic visits remained empirical and outdated whether for new or refitting existing contact lens wearers[3] .
Currently, a new soft contact lens wearer may need to visit an ECP several times to finalise a fitting whether for a new or existing wearer, and whether this is a spherical, or toric lens, which can consume significant ECP chair time and may cause patient inconvenience. Given the clinical performance and success rates with contemporary soft contact lenses, and possibility of fitting support with online tools and a range of virtual consultation options, the number of in person visits could be reduced.
The global market in terms of lens replacement in 2023, about half of all lenses prescribed were daily disposables (DD) and one third were monthly replaced contact lenses. In the United Kingdom, more than 60% of contact lens fits were DD which has been steadily increasing over the last few decades [5]. The increase in popularity of DD lenses is also supported by minimised risk of significant and non-significant adverse events related to these lenses, however the absolute rates and risks of microbial keratitis (MK) has remained consistent at 2-4 per 10,000 contact lens wearers per year [6].
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
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 to 40 years
- •Willing to use the prescribed soft daily disposable contact lenses
- •Normal ocular health
- •Rx range from +8.00 to -12.00DS and up to 2.50DC (within range that could be fitted by CV 1 day CLs)
- •Willing to provide written consent in English
- •Can attain good vision: Best-corrected visual acuity of 6/12 or better in each eye
- •Have no history of ocular surgery, injury, recent or current infection within the last 3 months
- •Have no known allergies to the study products
- •Willing to attend the scheduled study visits and adhere to instructions
- •If taking fish oil or tear supplements, should have started at least 3 months prior to starting the study and not planned changes to supplement intake during the study
排除标准
- •RGP, Extended Wear (re-usable), presbyopic, therapeutic/cosmetic, or myopia control contact lens wear
- •Experienced contact lens wearer with a history of regular lens wear more than 3 months
- •Unstable refractive error
- •Binocular vision anomaly not controlled by contact lenses
- •Patients require Presbyopic correction or age more than 40 years
- •Age < 18 years old
- •Not on a stable medication
- •Participation in another clinical trial within 2 weeks of participation in this study
- •History or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety
- •Self-reported pregnancy or lactation
- •Any ocular or systemic condition that may contradict contact lens wear ** *The investigator has the right to exclude any patient's participation in the study if he/she deems it to be in the best interest of the patient. Minor exceptions to the inclusion / exclusion criteria will be submitted to, and considered by, the Pl and approved as required. This includes 'drop-outs' that subsequently return to contact lens wear during the study trial.
- •OO/CLO (ECP) Clinical Judgement
研究组 & 干预措施
Cohort 1- In-person
Receives In-person Scheduled Contact Lens Aftercare
Cohort 2 - Remote
Receives Telecommunication Scheduled Contact Lens Aftercare
结局指标
主要结局
Safe and effective lens wear for first 1 year of contact lens wear
时间窗: Following Patient for One Year
Phone Aftercare Adequately Safe and effective
次要结局
- Satisfaction patient comfort with the number of follow up visits after one year(One Year)
研究者
Debarun Dutta
Doctor Senior Lecturer, School of Optometry
Aston University
