Enhancing Scleral Lens Fit With Advanced Imaging (NCT06751615) | Clinical Trial Compass
By InvitationNot Applicable
Enhancing Scleral Lens Fit With Advanced Imaging
Spain30 participantsStarted 2024-12-01
Plain-language summary
The goal of this experimental clinical trial is to enhance the predictability and precision of scleral lens fitting in patients with complex corneal conditions such as keratoconus, post-surgical irregularities, and severe dry eye syndrome. The main questions it aims to answer are:
Can detailed sagittal height measurements obtained from the Oculus Pentacam Corneal Scleral Profile (CSP) predict the necessary adjustments for optimal scleral lens fit? Will the use of these measurements reduce the number of trial-and-error adjustments needed to achieve an ideal fit, thereby reducing chair time and improving patient satisfaction?
Participants will:
Undergo detailed corneal and scleral tomography using the Oculus Pentacam with the CSP strategy.
Receive customized ICD 16.5 mm scleral lenses based on precise measurements of their ocular surface.
Participate in follow-up assessments to evaluate the fit of the lenses and provide feedback on comfort and visual outcomes.
This study focuses on a specific participant population of adults aged 18 and older who have not had success with other types of contact lenses. By leveraging advanced imaging technologies, the research aims to streamline the fitting process for scleral lenses, potentially setting new standards for treatment efficacy in specialty contact lens practices.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years and older. Diagnosed with keratoconus, post-corneal transplant irregularities, or severe dry eye disease, which are indicated for scleral lens usage.
Previous intolerance or inability to use other types of contact lenses such as soft or rigid gas-permeable lenses.
Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Adequate ocular health suitable for contact lens wear, except for conditions being treated in the study.
Ability to give informed consent.
Exclusion Criteria:
* Under 18 years of age. Active ocular infection or inflammation. History of herpetic keratitis. Severe allergies or contraindications to any component of the scleral lenses or imaging dyes used in the study.
Any condition which, in the opinion of the investigator, may interfere with safe participation in the study or adherence to study procedures.
Participation in another simultaneous clinical trial that might confound the results of the current study.
Pregnant or breastfeeding women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive Accuracy of Sagittal Height for Scleral Lens Fit
Timeframe: Throughout the study duration, from initial measurement to final lens fitting (approximately 6 months)