Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network
NCT ID: NCT06312163
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
120 participants
OBSERVATIONAL
2022-06-06
2023-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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 participant's 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Corneal and Scleral RGP Lenses on Ocular Health and Visual Quality in Keratoconus
NCT06921967
Combined Corneal Wavefront-guided TPRK and ACXL Following ICRS Implantation in Management of Moderate Keratoconus
NCT04383301
Scleral Versus Corneal RGP Contact Lenses in Irregular Cornea Disorders
NCT02444923
A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus
NCT06119321
Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP Contact Lens
NCT03971227
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ARM1
The contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design)
The contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design). A CE (UKCA) marked class 2 medical devices.
The participants will be fitted with (i) the optimal lens design as specified by the virtual fitting module, in addition to (ii) lenses that are one clinically significant step (0.12 mm) flatter and (iii) steeper in axial edge lift (AEL).
Arm2
The patient's own corneal RGP lens - CE (UKCA) marked class 2 medical devices.
The contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design). A CE (UKCA) marked class 2 medical devices.
The participants will be fitted with (i) the optimal lens design as specified by the virtual fitting module, in addition to (ii) lenses that are one clinically significant step (0.12 mm) flatter and (iii) steeper in axial edge lift (AEL).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design). A CE (UKCA) marked class 2 medical devices.
The participants will be fitted with (i) the optimal lens design as specified by the virtual fitting module, in addition to (ii) lenses that are one clinically significant step (0.12 mm) flatter and (iii) steeper in axial edge lift (AEL).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (a) Presence of keratoconus in either eye
* (b) Currently using a rigid gas permeable contact lens correction
* (c) Male or female, aged 18 years or older
* (d) The absence of significant media opacities
* (e) No ocular pathology other than keratoconus
* (f) Ability to understand nature/purpose of the study and to provide informed consent
* (g) Ability to follow instructions and complete the study
* (h) Ability to speak English
* WP2:
* (a) Presence of keratoconus in both eyes
* (b) Male or female, aged 18 years or older
* (c) The absence of significant media opacities
* (d) No ocular pathology other than keratoconus
* (e) Ability to understand nature/purpose of the study and to provide informed consent
* (f) Ability to follow instructions and complete the study
* (g) Ability to speak English
* WP3:
* (a) Optometrist, dispensing optician or ophthalmologist registered with the General Optical Council
* (b) Works within contact lens service at Moorfields Eye Hospital
* (c) Ability to understand nature/purpose of the study and to provide informed consent
* (d) Ability to follow instructions and complete the study
* (e) Ability to speak English .
Exclusion Criteria
* (a) Any systemic disease likely to affect visual performance
* (b) Any ocular disease that may affect visual performance, other than keratoconus
* (c) Hearing impairment sufficient to interfere with hearing instructions
* (d) Poor understanding of English language and/or alphabet
* (e) Any condition which, in the investigator's opinion, would conflict or otherwise prevent the participant from
* complying with the required procedures, schedule, or other study conduct.
* (f) Not currently using a rigid gas permeable contact lens or a contraindication to this
* (g) A history of corneal graft surgery (keratoplasty) in the eye under investigation.
* (h) A recent history (in preceding 12 months) of corneal abrasions in the designated study eye
* (i) A recent history (in preceding 1 month) of corneal cross linking for keratoconus
* WP2:
* (a) Any systemic disease likely to affect visual performance
* (b) Any ocular disease that may affect visual performance, other than keratoconus
* (c) Hearing impairment sufficient to interfere with hearing instructions
* (d) Poor understanding of English language and/or alphabet
* (e) Any condition which, in the investigator's opinion, would conflict or otherwise prevent the participant from
* complying with the required procedures, schedule, or other study conduct.
* (f) A contraindication to rigid gas permeable contact lens wear
* (g) A history of corneal graft surgery (keratoplasty) in the eye under investigation.
* (h) A recent history (in preceding 12 months) of corneal abrasions in the either eye
* (i) A recent history (in preceding 1 month) of corneal cross linking for keratoconus
* WP3:
* (a) An optometrist dispensing optician or ophthalmologist not fully registered with the General Optical Council (e.g., a pre-registration optometrist)
* (b) Hearing impairment sufficient to interfere with hearing instructions
* (c) Poor understanding of English language and/or alphabet
* (d) Any condition which, in the investigator's opinion, would conflict or otherwise prevent the participant from complying with the required procedures, schedule, or other study conduct.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Moorfields Eye Hospital NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EHRD1001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.