KeratoconusSPLEPICANCT06751615
Enhancing Scleral Lens Fit With Advanced Imaging
An observational study of Keratoconus and Astigmatism High, run by Fernando Fernandez Velazquez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus, Astigmatism High
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll 30 eyes from approximately 16 to 18 participants, predominantly adults ranging from 18 to 60 years old, with an average age of around 39.7 years. The participants will consist of a diverse group, primarily diagnosed with keratoconus, which accounts for the majority of the study population. Additionally, individuals with post-surgical corneal irregularities and severe dry eye syndrome, who have shown intolerance or are unable to use other types of contact lenses such as soft or rigid gas-permeable lenses, will also be included. This population is chosen because these conditions typically present challenges in achieving optimal vision correction through conventional means, making them ideal candidates for the benefits offered by scleral lenses. The study aims to refine the fitting process of ICD 16.5 mm scleral lenses using advanced Pentacam CSP imaging to achieve better comfort, fit, and visual outcomes. Patients will be consecutively recruited based on their cli
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Scleral Insight: Enhancing the Predictability of ICD Scleral Lens Fitting Using Pentacam Corneal Scleral Profile Analysis in Madrid, Spain
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?
Read more
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.
Read the detailed description
This prospective, single-center clinical trial aims to refine the process of fitting scleral lenses by utilizing advanced imaging technologies to enhance the precision and predictability of lens adaptations for individuals with complex corneal conditions. Conducted at Centro Fernández in Madrid, Spain, the study focuses on patients who have historically struggled with standard contact lens solutions due to conditions such as keratoconus, post-surgical corneal irregularities, and severe dry eye syndrome.
Study Objectives:
The primary objective of the study is to determine if detailed sagittal height measurements obtained from the Oculus Pentacam CSP can predict the necessary adjustments required for an optimal scleral lens fit. The secondary objective is to assess whether the use of these precise measurements can reduce the number of adjustments and follow-up visits typically required, thus improving overall patient satisfaction and clinical efficiency.
Methods and Procedures:
Participants will be enrolled based on specific inclusion criteria, including a history of intolerance or incompatibility with other forms of contact lenses. The study will include the following steps:
Initial Evaluation: Comprehensive ocular surface assessment using the Oculus Pentacam, which provides detailed corneal and scleral topography.
Lens Fitting: Custom scleral lenses will be fitted based on the Pentacam CSP measurements, with a focus on achieving a central vault of approximately 300 microns over the cornea.
Follow-Up Assessments: Participants will return for follow-up visits to assess the fit of the lenses, comfort, and visual outcomes. Adjustments to the lenses will be made based on these assessments.
Imaging and Technology:
The Oculus Pentacam CSP is a pivotal tool in this study, offering high-resolution imaging that captures detailed topographical data of both the cornea and sclera. This data is crucial for customizing each scleral lens to the unique contours of the patient's ocular surface, potentially reducing the iterative nature of traditional scleral lens fittings.
Expected Outcomes:
The study is expected to produce several key outcomes:
Validation of Predictive Models: Establishing reliable predictive models correlating sagittal height measurements with lens fitting parameters.
Clinical Efficiency: Reduction in the total number of fitting sessions required, as well as decreased chair time during each visit.
Patient Satisfaction: Improvement in patient comfort and visual acuity, leading to higher satisfaction rates.
Impact on Clinical Practice:
By demonstrating the effectiveness of integrating advanced imaging technologies into the scleral lens fitting process, this study aims to influence current practices significantly. It is anticipated that the results will provide evidence-based guidelines that can be adopted widely, leading to more predictable and efficient scleral lens fittings across various clinical settings.
- Conditions
- Keratoconus, Astigmatism High
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Advanced ICD Fitting with Pentacam CSP | This cohort involves a single group of patients who will undergo an innovative scleral lens fitting process using the Oculus Pentacam Corneal Scleral Profile (CSP) analysis. The intervention focuses on enhancing the precision and predictability of ICD scleral lens adaptations by utilizing advanced imaging techniques to measure corneal and scleral topography. Participants will receive custom-fitted ICD scleral lenses designed based on detailed ocular surface measurements captured by Pentacam CSP. The main goal is to achieve optimal fitting with reduced chair time and fewer adjustment visits. The Pentacam CSP provides high-resolution, three-dimensional scans of the anterior segment, allowing for precise mapping of both the cornea and sclera. This data is crucial for determining the appropriate sagittal depth and lens curvature needed for each patient, aiming to enhance comfort and visual outcomes. By integrating these measurements, the study seeks to develop a more efficient and effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Accuracy of Sagittal Height for Scleral Lens Fit
This primary outcome measure evaluates the predictive accuracy of sagittal height measurements obtained using the Oculus Pentacam at 10 mm, limbus, and 15 mm in determining the necessary adjustments to achieve optimal scleral lens fit. The main goal is to establish how closely the sagittal heights at these specific points predict the required lens sagittal depth to achieve a targeted central vault of approximately 300 microns. This outcome will assess the effectiveness of using Pentacam CSP data to reduce the number of fitting sessions and adjustments, thereby increasing the efficiency of the scleral lens fitting process. The expected result is a validated predictive model correlating specific sagittal height measurements with precise lens fitting parameters, potentially setting new standards for custom scleral lens adaptations.
Measured: Throughout the study duration, from initial measurement to final lens fitting (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Dec 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernando Fernandez Velazquez
- Sponsor type
- Research network
- Collaborators
- Centro de Miopía Fernández-Velázquez
- Responsible party
- Sponsor-investigator, Fernando Fernandez Velazquez, Centro de Miopía Fernández-Velázquez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751615
- Sponsor's protocol ID
- CMFV-SCL-2024-03
- Acronym
- SPLEPICA
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleral Insight: Enhancing the Predictability of ICD Scleral Lens Fitting Using Pentacam Corneal Scleral Profile Analysis in Madrid, Spain
- ClinicalTrials.gov ID
- NCT06751615
- Acronym / sponsor ID
- SPLEPICA / CMFV-SCL-2024-03
- Conditions
- Keratoconus, Astigmatism High
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fernando Fernandez VelazquezResearch network
- Collaborators
- Centro de Miopía Fernández-Velázquez
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, single-center clinical trial aims to refine the process of fitting scleral lenses by utilizing advanced imaging technologies to enhance the precision and predictability of lens adaptations for individuals with complex corneal conditions. Conducted at Centro Fernández in Madrid, Spain, the study focuses on patients who have historically struggled with standard contact lens solutions due to conditions such as keratoconus, post-surgical corneal irregularities, and severe dry eye syndrome.
Study Objectives:
The primary objective of the study is to determine if detailed sagittal height measurements obtained from the Oculus Pentacam CSP can predict the necessary adjustments required for an optimal scleral lens fit. The secondary objective is to assess whether the use of these precise measurements can reduce the number of adjustments and follow-up visits typically required, thus improving overall patient satisfaction and clinical efficiency.
Methods and Procedures:
Participants will be enrolled based on specific inclusion criteria, including a history of intolerance or incompatibility with other forms of contact lenses. The study will include the following steps:
Initial Evaluation: Comprehensive ocular surface assessment using the Oculus Pentacam, which provides detailed corneal and scleral topography.
Lens Fitting: Custom scleral lenses will be fitted based on the Pentacam CSP measurements, with a focus on achieving a central vault of approximately 300 microns over the cornea.
Follow-Up Assessments: Participants will return for follow-up visits to assess the fit of the lenses, comfort, and visual outcomes. Adjustments to the lenses will be made based on these assessments.
Imaging and Technology:
The Oculus Pentacam CSP is a pivotal tool in this study, offering high-resolution imaging that captures detailed topographical data of both the cornea and sclera. This data is crucial for customizing each scleral lens to the unique contours of the patient's ocular surface, potentially reducing the iterative nature of traditional scleral lens fittings.
Expected Outcomes:
The study is expected to produce several key outcomes:
Validation of Predictive Models: Establishing reliable predictive models correlating sagittal height measurements with lens fitting parameters.
Clinical Efficiency: Reduction in the total number of fitting sessions required, as well as decreased chair time during each visit.
Patient Satisfaction: Improvement in patient comfort and visual acuity, leading to higher satisfaction rates.
Impact on Clinical Practice:
By demonstrating the effectiveness of integrating advanced imaging technologies into the scleral lens fitting process, this study aims to influence current practices significantly. It is anticipated that the results will provide evidence-based guidelines that can be adopted widely, leading to more predictable and efficient scleral lens fittings across various clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Advanced ICD Fitting with Pentacam CSP | – | –This cohort involves a single group of patients who will undergo an innovative scleral lens fitting process using the Oculus Pentacam Corneal Scleral Profile (CSP) analysis. The intervention focuses on enhancing the precision and predictability of ICD scleral lens adaptations by utilizing advanced imaging techniques to measure corneal and scleral topography. Participants will receive custom-fitted ICD scleral lenses designed based on detailed ocular surface measurements captured by Pentacam CSP. The main goal is to achieve optimal fitting with reduced chair time and fewer adjustment visits. The Pentacam CSP provides high-resolution, three-dimensional scans of the anterior segment, allowing for precise mapping of both the cornea and sclera. This data is crucial for determining the appropriate sagittal depth and lens curvature needed for each patient, aiming to enhance comfort and visual outcomes. By integrating these measurements, the study seeks to develop a more efficient and effect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll 30 eyes from approximately 16 to 18 participants, predominantly adults ranging from 18 to 60 years old, with an average age of around 39.7 years. The participants will consist of a diverse group, primarily diagnosed with keratoconus, which accounts for the majority of the study population. Additionally, individuals with post-surgical corneal irregularities and severe dry eye syndrome, who have shown intolerance or are unable to use other types of contact lenses such as soft or rigid gas-permeable lenses, will also be included. This population is chosen because these conditions typically present challenges in achieving optimal vision correction through conventional means, making them ideal candidates for the benefits offered by scleral lenses. The study aims to refine the fitting process of ICD 16.5 mm scleral lenses using advanced Pentacam CSP imaging to achieve better comfort, fit, and visual outcomes. Patients will be consecutively recruited based on their cli
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive Accuracy of Sagittal Height for Scleral Lens Fit
Time frame: Throughout the study duration, from initial measurement to final lens fitting (approximately 6 months)
This primary outcome measure evaluates the predictive accuracy of sagittal height measurements obtained using the Oculus Pentacam at 10 mm, limbus, and 15 mm in determining the necessary adjustments to achieve optimal scleral lens fit. The main goal is to establish how closely the sagittal heights at these specific points predict the required lens sagittal depth to achieve a targeted central vault of approximately 300 microns. This outcome will assess the effectiveness of using Pentacam CSP data to reduce the number of fitting sessions and adjustments, thereby increasing the efficiency of the scleral lens fitting process. The expected result is a validated predictive model correlating specific sagittal height measurements with precise lens fitting parameters, potentially setting new standards for custom scleral lens adaptations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoconus
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus and Astigmatism High, run by Fernando Fernandez Velazquez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Accuracy of Sagittal Height for Scleral Lens Fit (time frame: Throughout the study duration, from initial measurement to final lens fitting (approximately 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.