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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.
Full description
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range of virtual assessment tools, contact lens aftercare and frequency of routine clinic visits remained empirical and outdated whether for new or refitting existing contact lens wearers[3] .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].
Given DD lenses bypass direct dependence on multipurpose care solutions and cases, the matter of patient convenience has also made DD lenses more popular than ever. Patients also have spare lenses available in the event of loss or damage. DD lenses have less chance of spoilation from lens deposits and minimum chance of exposure to pathogenic microorganisms which may lead to microbial adverse events [7]. In addition, a wide range of spherical and toric DD lenses are currently available, which typically range between +8.00 Ds to -12.00Ds, whereas up to 2.25 Dc astigmatic corrections are available. DD contact lens wear is reported to maintain high patient comfort and visual acuity, coupled with the wide range of available parameters underpin high patient comfort and visual satisfaction [8, 9].
Objectives:
Project objective is to evaluate the current provision and frequency of patient follow up visits required for a new or experienced contact lens fit.
A clinical study is proposed to determine the number of follow up appointments required for optimal clinical and satisfactory outcomes in the weeks following a soft contact lens fitting, for both neophytes and existing wearer refits, and investigate delivery of care across different channels such as remote when appropriate.
Endpoints:
Study design:
A controlled, open label, 4-arm study will be designed where daily disposable new lens wearers (neophytes) will be assigned into four groups. The study will receive human ethics committee approval and will be registered with a clinical trial registry.
The study will have the following visits (Table 1 for phase-I and table 2 for phase-II) and follow ups scheduled over a duration of 1 year (365 ± 60 days) and will be conducted in support with independent UK practices and those from the Specsavers Group. Coopervision daily disposable spherical and toric lenses will be used. An experienced lens wearer is designated to a participant who has worn lenses more than 3 months in lifetime, anyone with less experience of lens wear is designated as an inexperienced lens wearer (neophytes). Patient satisfaction and comfort will be scored in 1-10 (1 being highly unsatisfied or uncomfortable). Similarly, ECP satisfaction will be graded 1-10 (1 being highly unsatisfied).
Sample size: A total of 65 new contact lens wearers (neophytes) for cohort 1 and 2, and 60 experienced wearers for cohort 3 and 4 will be recruited (Table 1 and 2 respectively), totalling to 250 patients. Calculation was based on identifying significant difference in patient comfort after 1 year of lens wear with 80% power, significance 0.05(G*Power). The dropout rate for experienced contact lens wearers can be up to 25% over 1 year of wear, requiring 60 participants for each cohort. Whereas dropout rates for new contact lens wearers during 1st year can be up to 35% [7], requiring 65 participants.
Table 1 (Phase I) Visit number Control cohort-1 with empirical visits for neophytes (n=65) Test cohort-2 with modified visits for neophytes (n=65) 1.0 Initial assessment and fitting with or without teach and collection of CLs (Day 0) Initial assessment and fitting with or without teach and collection of CLs (Day 0) 1.1 Teaching visit (Day 0+10 days) (unscheduled visit - if required) Teaching visit (unscheduled visit - if required) 2.0 Follow up in office assessment (Day 14 ± 10 days) Follow-up telephone call* (Day 14±10 days) 3.0 Follow up in office assessment (Day 365 ± 60 days)# Follow up in office assessment (Day 365 ± 60 days)# Any additional call/visit will be termed as 'unscheduled visit'. Any visit not within window period will be termed as 'late visit', but all will be recorded.
Table 2. (Phase II) Visit number Control cohort-3 with empirical visits experienced wearers (n=60) Test cohort-4 with modified visits experienced wearers (n=60) 1.0 Initial assessment and fitting with or without teach (Day 0)
Initial assessment and fitting with or without teach (Day 0)
1.1 Teaching and collection if needed (Day 7±4days) Teaching and collection if needed (Day 7±4days) 2.0 Follow up in office assessment (Day 14 ± 10 days following collection of CLs) Follow-up telephone call* (Day 14 ± 10 days following collection of CLs) 3.0 Follow up in office assessment (Day 365 ± 30 days) Follow up in office assessment (Day 365 ± 30 days) Any additional call/visit will be termed as 'unscheduled visit'. Any visit not withing window period will be termed as 'late visit'.
Data collection for each visit will include:
Visit 1.0 and 3.0 (all cohorts):
This will include comprehensive ocular assessments such as: visual acuity, detailed slit lamp assessments for anterior eye, lens fit assessment and ocular comfort (1-10). These are listed below:
Reason of wear
General history
Allergies
Ocular history
Contact lens wear history (cohort 3 and 4)
Occupation / hobbies
Lens details/parameters
Best Corrected Visual Acuity (BCVA)
Detailed slit lamp assessments of anterior eye including Lids /lashes Conjunctiva Limbus Neovascularisation / Oedema Cornea / Staining
Soft contact lens fitting Parameters HVID Pupil diameter Keratometry/topography Centration and coverage Blink movement Lag Push up test Overall impression/other comments Comfortable with self application and removal - Yes/ No (visit 1.0 only: if teaching included) Other notes
Patient Comfort (visit 3.0 only, scores 1-10; where 1 highly uncomfortable and 10 very comfortable)
Patient satisfaction (visit 3.0 only, scores 1-10; where 1 highly uncomfortable and 10 very comfortable)
Ease of lens handling/application and removal (1-10; 10 being very easy; if teaching is done in visit 1.0)
Practitioner satisfaction with patient follow ups (visit 3.0 only, scores 1-10; where 1 highly unsatisfied and 10 highly satisfied) Visit 1.1 (all cohorts)
Teaching of lens application and removal, which will include explaining to the patient about the type, storage, safety and compliance.
Ease of lens handling/application and removal (1-10; 10 being very easy; if teaching is not done visit 1.0)
Performed by ECP/someone else Visit 2.0 (cohort 1 and 3 with in person follow ups)
Reason for visit
Age of lens / modality / solution (NA for this study/SS might have in clinic form)
History and symptoms to mirror those for the remote cohort.
Wear times Hrs/day Days/week
Vision with lens
Over refraction
Final VA
Lens fitting assessments Centration and coverage Blink movement Lag Push up test Overall impression/other comments
Detailed slit lamp assessments of anterior eye including Lids /lashes Conjunctiva Limbus Neovascularisation / Oedema Cornea / Staining
Hours of lens wear/day
Comfort at the start and end of lens wear: rate 1-10 (10 being highly comfortable)
Ease of lens handling/application and removal (1-10; 10 being very easy)
Comfort score 1-10 (1 being very uncomfortable)
*Visit 2.0 (cohort 2 and 4 clinician led telephone call)
Greetings and overall wellbeing, check lens specs, any changes in symptoms / experience since last visit (any significant change reported by patient would trigger in person visit)
Vision with contact lens - rate 1-10 (10 being highly satisfactory) any changes in vision throughout day of wear
Duration of lens wear (hr) per day / days per week
Hours of comfortable lens wear per day
Comfort at the start and end of lens wear: rate 1-10 (10 being highly comfortable)
Ease of lens handling/application and removal (1-10; 10 being very easy)
Any significant eye redness, discomfort, discharge, other adverse events, any other issues (yes will trigger in person visits)
Confirm next follow up and provide contact details for any questions
Thank you
Inclusion/exclusion criteria:
Inclusion criteria
Inclusion/exclusion exceptions:
Informed consent:
Prior to the screening visit, participants will be provided with an informed consent form and be given the chance to review and ask questions before written informed consent is obtained. The participant will sign and date the informed consent form.
Statistical analysis: Paired-t-test, Repeated measures ANOVA or linear mixed model analysis using Bonferroni adjustment for multiple comparisons and P-value set at p<0.05.
Dissemination plan: sample
Budget:
Funded 50:50 by Coopervision and Aston University
References:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age between 18 to 40 years
Exclusion criteria
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.
300 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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