Scleral Lenses for Limbal Ring
(CHIMERA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new scleral lenses designed to fit the natural oval shape of the limbus, the border area of the eye. The goal is to determine if these lenses provide better comfort and fit than traditional round lenses, potentially enhancing eye health for users. Participants will receive custom-made lenses using advanced eye imaging and computer modeling. The trial suits current WAVE ScleraLens users who have full legal capacity and can attend appointments. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiming to understand its benefits for more patients.
What is the safety track record for scleral lenses?
Research shows that scleral lenses, like those tested in the study, are generally safe and comfortable. Studies have found that these lenses effectively manage various eye conditions, such as severe dry eye and irregular corneas, without major safety issues.
Evidence indicates that circular limbal zone lenses safely improve vision and comfort for individuals with eye conditions, often resulting in clearer vision and fewer visual distortions.
Oval limbal zone lenses are designed to enhance comfort and fit. Research suggests that these lenses significantly improve clarity and reduce vision errors, demonstrating their safety and effectiveness.
Both types of lenses are already approved and available in Canada, providing extra reassurance about their safety for potential trial participants.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about scleral lenses for limbal ring enhancement because they offer a unique customization opportunity compared to traditional contact lenses. Unlike standard contacts, these lenses are designed with specialized software to create either a circular or oval limbal zone, which can potentially improve comfort and visual acuity. This precise customization could lead to better fitting lenses that are more comfortable for extended wear, addressing common issues with dryness and irritation found in conventional options. By tailoring the lens fit more accurately to the eye's shape, these lenses may provide a significant advancement in comfort and visual performance for users.
What evidence suggests that this trial's scleral lens designs could be effective for improving comfort and fit?
Studies have shown that scleral lenses can greatly improve vision clarity. One study demonstrated an improvement from a score of 0.42 to 0.05 on a specific scale. These lenses are also known for their comfort and ability to increase overall user satisfaction. In this trial, participants will receive either scleral lenses with a circular limbal zone or those with an oval limbal zone. Research indicates that lenses with a toric landing zone, shaped more like an oval, provide better comfort and vision quality than traditional round lenses. Early findings suggest that lenses with an oval limbal zone might fit better and feel more comfortable over the limbus (the border area of the eye) than round lenses. Customizing the lens shape to fit the eye more naturally could enhance both comfort and long-term eye health.13678
Who Is on the Research Team?
Lyndon Jones, PhD, FCOptom
Principal Investigator
University of Waterloo
Are You a Good Fit for This Trial?
This trial is for individuals who use scleral lenses, which are large contact lenses that cover the white part of the eye. Participants should be interested in improving their lens fit and comfort, especially if they have conditions like keratoconus or dry eyes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are fitted with scleral lenses designed with either circular or oval limbal zones and evaluated for fit and comfort
Follow-up
Participants are monitored for limbal clearance and comfort with the lenses
What Are the Treatments Tested in This Trial?
Interventions
- Scleral Lenses
Trial Overview
The study is testing whether scleral lenses with an oval-shaped limbal zone provide a better fit than traditional round designs. It involves advanced imaging to measure each participant's eye shape and customize the lens design accordingly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Scleral lenses with an oval limbal zone designed with a scleral lens custom design software (WAVE Contact Lens System)
Scleral lenses with a circular limbal zone designed with a scleral lens custom design software (WAVE Contact Lens System)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Waterloo
Lead Sponsor
Fighting Blindness Canada
Collaborator
Canadian Optometric Education Trust Fund (COETF)
Collaborator
Citations
Comparing the Fit and Performance of Scleral Lenses With ...
These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, ...
2.
ctv.veeva.com
ctv.veeva.com/study/comparing-the-fit-and-performance-of-scleral-lenses-with-oval-and-circular-limbal-zonesComparing the Fit and Performance of Scleral Lenses With ...
This study will test whether lenses designed with an oval-shaped limbal zone provide a better fit and greater comfort than traditional round ...
Impact of Scleral Lenses on Visual Acuity and Ocular ...
Their findings revealed a significant improvement in CDVA, with the mean logMAR improving from 0.42 to 0.05 (p < 0.001) after SL fitting. This ...
4.
researchgate.net
researchgate.net/publication/387816000_Long-Term_Effectiveness_of_Scleral_Lens_Treatment_in_the_Management_of_Keratoconus_A_Systematic_Review(PDF) Long-Term Effectiveness of Scleral Lens Treatment ...
Long-term follow-up indicated that 14.6% of the patients experienced worsening visual acuity due to keratoconus progression. Methodological ...
5.
clspectrum.com
clspectrum.com/issues/2020/september/scleral-shape-and-its-application-for-scleral-lens-fitting/SCLERAL SHAPE AND ITS APPLICATION FOR ...
Patients wearing scleral lenses with toric landing zones reported improved comfort, vision quality, and overall satisfaction compared with ...
Short-Term Efficacy and Safety of Scleral Lenses in the ... - PMC
Short-term efficacy and safety of scleral lenses in the management of severe dry eye in a Chinese population.
7.
dovepress.com
dovepress.com/bibliometric-and-visual-analysis-of-the-status-of-scleral-lens-researc-peer-reviewed-fulltext-article-OPTOBibliometric and Visual Analysis of the Status of Scleral ...
The objective is to furnish clinicians with valuable insights to optimize lens wear and enhance patient outcomes, ultimately aiming to improve ...
Update on indications, complications, and outcomes of scleral ...
Currently, SCLs can successfully be used to manage ocular surface diseases, visually rehabilitate irregular corneas, and correct irregular refractive errors.
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