KeratoconusVISIONNCT06312163

Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network

An observational study of Keratoconus, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Keratoconus
What is being tested?: 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.
Type of treatment: Medical device
How many people: 120 participants
Where: 1 siteUnited Kingdom
Study dates: 6 Jun 2022to 15 Dec 2023
Phase: Observational
Are there results?: None posted in the registry

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
Healthy volunteers accepted
Adult, Older adult

Study population: Patients with keratoconus (KC) attending Moorfields contact lens clinics

Who may be able to join

- WP1:
(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

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(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 .

Who cannot join

- WP1:
(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

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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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD

Other trials in United Kingdom

About this study

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.

Conditions: Keratoconus
Being tested: 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.
Keywords: rigid gas permeable contact lens
Medical subject headings: Keratoconus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.Device
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).

Study groups in NCT06312163
Study group	Role	What they receive
ARM1		The contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design) Receives: Device: 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.
Arm2		The patient's own corneal RGP lens - CE (UKCA) marked class 2 medical devices. Receives: Device: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Rigid gas permeable contact lens fit
The CL fit will be assessed through (i) slit lamp photography according to the standardised method proposed by Wolffsohn et al. (2013), (ii) slit lamp video of lens movement following blink in the primary position and horizontal version movements, and (iii) Anterior segment OCT MS39) (CSO Hansom Instruments, UK).
Measured: 18 months

Secondary outcomes (3)

The changes in contact lens fit from increased and decreased Axial Edge lift
Fluorescein intensity measures Wolffsohn et al. (2013) will be used to examine the predicted vs. observed alterations in contact lens fit when AEL is varied
Measured: 18 months
Best corrected Visual Acuity
Best-corrected visual acuity with each lens design (incorporating an over-refraction where needed) will be measured using high-contrast logMAR in a forced-choice manner.
Measured: 18 months
Clinician Usability Assessment
Clinician Usability Assessment of topography guided virtual contact lens selection module
Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 202215 Dec 2023

First posted15 Mar 2024
Study start6 Jun 2022
Primary completion15 Dec 2023
Study completion15 Dec 2023

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: Prospective
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06312163
Sponsor's protocol ID: EHRD1001
Acronym: VISION
Status last verified: Mar 2024
First submitted: 8 Mar 2024
Last updated: 15 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
UNITY DX Cornea Study
Tomography
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
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable

All Keratoconus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Innovative Scheimpflug Topography Derived RGP Contact Lens Designs In Optometry Network
ClinicalTrials.gov ID: NCT06312163
Acronym / sponsor ID: VISION / EHRD1001
Conditions: Keratoconus
Keywords: rigid gas permeable contact lens
Study type: Observational
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
Study start: 6 Jun 2022 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 15 Mar 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.

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.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
ARM1	–	Device: 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 contact lens to be investigated in this study (Scheimpflug topography derived corneal RGP contact lens design)
Arm2	–	Device: 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 patient's own corneal RGP lens - CE (UKCA) marked class 2 medical devices.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients with keratoconus (KC) attending Moorfields contact lens clinics

Key inclusion criteria (23 listed)

- WP1:
(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

Key exclusion criteria (27 listed)

- WP1:
(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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Device	ARM1, Arm2

Primary outcome

Rigid gas permeable contact lens fit
Time frame: 18 months
The CL fit will be assessed through (i) slit lamp photography according to the standardised method proposed by Wolffsohn et al. (2013), (ii) slit lamp video of lens movement following blink in the primary position and horizontal version movements, and (iii) Anterior segment OCT MS39) (CSO Hansom Instruments, UK).

3 secondary outcomes

The changes in contact lens fit from increased and decreased Axial Edge lift
Time frame: 18 months
Best corrected Visual Acuity
Time frame: 18 months
Clinician Usability Assessment
Time frame: 18 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.

Related trials for Keratoconus

RecruitingObservational study
UNITY DX Cornea Study
Tomography
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
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. This study is not recruiting at the moment.

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, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.

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 23 inclusion and 27 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: finished, as of the sponsor's last update on 15 Mar 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 United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rigid gas permeable contact lens fit (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06312163.

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 15 Mar 2024.