Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312163
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network
Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Organization:
Moorfields Eye Hospital NHS Foundation Trust
Study Overview
Official Title:
Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISION
Brief Summary:
The goal of this Prospective single-site cohort study is to validate rigid gas permeable corneal contact lens RGP designs for keratoconus derived from combining the data from corneal topography scans and contact lenses ordered in patients with keratoconus KC attending a UK tertiary NHS Hospital contact lens clinic The main questions it aims to answer are
Does a Scheimpflug topography derived RGP contact lens design for keratoconus have the equivalent overall contact lens fit as the patients own lens
Is the number of trial lenses required to fit a patient is reduced compared to standard practice
Is the time taken to fit a contact lens is reduced compared to standard practice
Is there user acceptance of the new lens
Are the Axial ege lift AEL changes clinically significant
There will be 3 work packages
WP1 For each participant data collection will take place over two visits
Visit 1 Pentacam topography scans and optimal virtual lens selection will take place Visit 2 Participants are fitted with 4 contact lenses i the optimal lens design as specified by the virtual fitting module ii a contact lens with a clinically significant step flatter AEL iii a contact lens steeper in axial edge lift AEL iv the participants own contact lens
Each CL fit will be assessed with slit lamp photography according to the standardised method proposed by Wolffsohn et al 2013 Anterior segment OCT MS39 CSO Hansom Instruments UK and best-corrected visual acuity with each lens design using high-contrast logMAR
WP2 Participants will attend one appointment where a traditional lens fit and a lens fitted using the topography guided virtual module will be undertaken with the fitting method selected for each eye randomised For each fitting method the total fitting time will be measured and the total number of trial contact lenses used Patients will be invited to complete a questionnaire that probes their satisfaction of this process
WP3 Clinicians not involved in the study will be invited to examine a demo version of the virtual fitting module and complete the validated system usability scale tool
Does a Scheimpflug topography derived RGP contact lens design for keratoconus have the equivalent overall contact lens fit as the patients own lens
Is the number of trial lenses required to fit a patient is reduced compared to standard practice
Is the time taken to fit a contact lens is reduced compared to standard practice
Is there user acceptance of the new lens
Are the Axial ege lift AEL changes clinically significant
There will be 3 work packages
WP1 For each participant data collection will take place over two visits
Visit 1 Pentacam topography scans and optimal virtual lens selection will take place Visit 2 Participants are fitted with 4 contact lenses i the optimal lens design as specified by the virtual fitting module ii a contact lens with a clinically significant step flatter AEL iii a contact lens steeper in axial edge lift AEL iv the participants own contact lens
Each CL fit will be assessed with slit lamp photography according to the standardised method proposed by Wolffsohn et al 2013 Anterior segment OCT MS39 CSO Hansom Instruments UK and best-corrected visual acuity with each lens design using high-contrast logMAR
WP2 Participants will attend one appointment where a traditional lens fit and a lens fitted using the topography guided virtual module will be undertaken with the fitting method selected for each eye randomised For each fitting method the total fitting time will be measured and the total number of trial contact lenses used Patients will be invited to complete a questionnaire that probes their satisfaction of this process
WP3 Clinicians not involved in the study will be invited to examine a demo version of the virtual fitting module and complete the validated system usability scale tool
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None