KeratoconusNCT03091101
Impact of Scleral Contact Lens Wear on Corneal Nerves in Keratoconus
A study testing Scleral lens wearing keratoconics in people with Keratoconus, run by University of Waterloo at 1 site in Canada.
Trial summary
The purpose of this study is to investigate changes in corneal innervation during scleral contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity and nerve fiber density from baseline in the central and mid-peripheral corneal locations will be measured over a 6-month lens wear… 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?
- Scleral lens wearing keratoconics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2017to 21 Mar 2018
- Phase
- Interventional
- 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
Who may be able to join
- Had been diagnosed with keratoconus in at least one eye.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
Who cannot join
- Have worn rigid corneal lenses for more than several days over the past year
- Is using any topical medications that will affect ocular health.
- Has any ocular pathology or systemic disease that may lead to severe insufficiency of lacrimal secretion (severe dry eyes) or corneal hypoesthesia which would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
- Is aphakic.
Show all 9Show fewer
- Has undergone any corneal surgery.
- Is participating in any other type of eye related clinical or research study.
- Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein and topical anesthetics, used in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Scleral Contact Lens Wear on Corneal Sensitivity, Nerve Morphology and Inflammation in Keratoconic Eyes
The purpose of this study is to investigate changes in corneal innervation during scleral contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity and nerve fiber density from baseline in the central and mid-peripheral corneal locations will be measured over a 6-month lens wear period. An additional aim of the study is to investigate the impact of scleral lens wear on corneal inflammation within the same study group. This will be achieved by comparing dendritic cell density change from baseline over the study period.
Read the detailed description
The human cornea is a densely innervated tissue that provides a high level of sensitivity to foreign objects or noxious substances. The innervation of the cornea also plays an important role in the tropic maintenance and repair of the corneal surface. Any alterations to the normal innervation of the cornea not only lessen the ability to detect foreign objects that could damage the ocular surface, but also reduce its wound healing ability. Previous studies have shown rigid contact lens wear reduces corneal sensitivity and nerve fiber density in keratoconic subjects. Scleral contact lenses are large diameter rigid gas permeable lenses that rests on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses is becoming one of the current standard nonsurgical management of corneal dystrophies such as keratoconus, mainly due to the improved comfort and vision quality compared to conventional rigid lenses. Despite these patient benefits, little is known about the impact of scleral contact lens wear on corneal sensitivity and nerve morphology in keratoconus.
The purpose of this study is to investigate changes in corneal innervation during scleral contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity and nerve fiber density from baseline in the central and mid-peripheral corneal locations will be measured over a 6-month lens wear period. An additional aim of the study is to investigate the impact of scleral lens wear on corneal inflammation within the same study group. This will be achieved by comparing dendritic cell density change from baseline over the study period.
The investigators propose to take a sample of keratoconic participants and fit them in scleral lenses and:
- Measure corneal sensitivity at two corneal locations before and after 1-month, 3-months and 6-months of scleral lens wear.
- Capture images of the sub-basal nerve plexus in vivo using laser-scanning confocal microscopy at similar corneal locations and study visits.
- Calculate nerve morphology parameters and dendritic cell density from these captured images.
Up to 15 participants will be enrolled.
- Conditions
- Keratoconus
- Being tested
- Scleral lens wearing keratoconics
- Keywords
- keratoconus, corneal innervation, scleral contact lenses
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scleral lens wearing keratoconicsDevice
Cohort of keratoconics fitted with scleral lenses and monitored over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Scleral lens wearing keratoconics | Experimental | Newly diagnosed keratoconics with no previous rigid lens wear fitted with Sceral contact lenses Receives: Device: Scleral lens wearing keratoconics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal sensitivity
Indication of functional change in corneal innervation from scleral lens wear by measuring change in sensitivity threshold (grams/sq.mm) over time
Measured: 6-month lens wear period
Subbasal nerve fiber density
Indication of morphological change in corneal innervation from scleral lens wear by measuring nerve fiber density changes (mm/sq.mm) in the central subbasal nerve fiber layer location over time.
Measured: 6-month lens wear period
Secondary outcomes (1)
Corneal inflammation
Changes in dendritic cell density (number/sq.mm) as a marker of corneal inflammation
Measured: 6-month lens wear period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start15 Mar 2017
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Precision Technology Services Ltd
- Responsible party
- Principal investigator, Edward Lum, University of Waterloo
- Investigators
- Edward Lum, PhD, Principal investigator, Univerity of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091101
- Sponsor's protocol ID
- ORE#21910
- Status last verified
- Jun 2018
- First submitted
- 15 Mar 2017
- Last updated
- 11 Jun 2018
- 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 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Scleral Contact Lens Wear on Corneal Sensitivity, Nerve Morphology and Inflammation in Keratoconic Eyes
- ClinicalTrials.gov ID
- NCT03091101
- Acronym / sponsor ID
- ORE#21910
- Conditions
- Keratoconus
- Keywords
- keratoconus, corneal innervation, scleral contact lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Precision Technology Services Ltd
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 27 Mar 2017 (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 purpose of this study is to investigate changes in corneal innervation during scleral contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity and nerve fiber density from baseline in the central and mid-peripheral corneal locations will be measured over a 6-month lens wear period. An additional aim of the study is to investigate the impact of scleral lens wear on corneal inflammation within the same study group. This will be achieved by comparing dendritic cell density change from baseline over the study period.
Detailed description
The human cornea is a densely innervated tissue that provides a high level of sensitivity to foreign objects or noxious substances. The innervation of the cornea also plays an important role in the tropic maintenance and repair of the corneal surface. Any alterations to the normal innervation of the cornea not only lessen the ability to detect foreign objects that could damage the ocular surface, but also reduce its wound healing ability. Previous studies have shown rigid contact lens wear reduces corneal sensitivity and nerve fiber density in keratoconic subjects. Scleral contact lenses are large diameter rigid gas permeable lenses that rests on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses is becoming one of the current standard nonsurgical management of corneal dystrophies such as keratoconus, mainly due to the improved comfort and vision quality compared to conventional rigid lenses. Despite these patient benefits, little is known about the impact of scleral contact lens wear on corneal sensitivity and nerve morphology in keratoconus.
The purpose of this study is to investigate changes in corneal innervation during scleral contact lens wear in a keratoconic population. Specifically, changes in corneal sensitivity and nerve fiber density from baseline in the central and mid-peripheral corneal locations will be measured over a 6-month lens wear period. An additional aim of the study is to investigate the impact of scleral lens wear on corneal inflammation within the same study group. This will be achieved by comparing dendritic cell density change from baseline over the study period.
The investigators propose to take a sample of keratoconic participants and fit them in scleral lenses and:
- Measure corneal sensitivity at two corneal locations before and after 1-month, 3-months and 6-months of scleral lens wear.
- Capture images of the sub-basal nerve plexus in vivo using laser-scanning confocal microscopy at similar corneal locations and study visits.
- Calculate nerve morphology parameters and dendritic cell density from these captured images.
Up to 15 participants will be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scleral lens wearing keratoconics | Experimental | Device: Scleral lens wearing keratoconicsNewly diagnosed keratoconics with no previous rigid lens wear fitted with Sceral contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Had been diagnosed with keratoconus in at least one eye.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
Key exclusion criteria (9 listed)
- Have worn rigid corneal lenses for more than several days over the past year
- Is using any topical medications that will affect ocular health.
- Has any ocular pathology or systemic disease that may lead to severe insufficiency of lacrimal secretion (severe dry eyes) or corneal hypoesthesia which would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
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 |
|---|---|---|
| Scleral lens wearing keratoconicsCohort of keratoconics fitted with scleral lenses and monitored over 6 months | Device | Scleral lens wearing keratoconics |
Primary outcome
Corneal sensitivity
Time frame: 6-month lens wear period
Indication of functional change in corneal innervation from scleral lens wear by measuring change in sensitivity threshold (grams/sq.mm) over time
Subbasal nerve fiber density
Time frame: 6-month lens wear period
Indication of morphological change in corneal innervation from scleral lens wear by measuring nerve fiber density changes (mm/sq.mm) in the central subbasal nerve fiber layer location over time.
1 secondary outcome
Corneal inflammation
Time frame: 6-month lens wear period
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 11 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Edward Lum, PhD principal investigator
Univerity of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scleral lens wearing keratoconics in people with Keratoconus, run by University of Waterloo at 1 site in Canada.
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 4 inclusion and 9 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 11 Jun 2018. 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 Canada. 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?
Corneal sensitivity (time frame: 6-month lens wear period). The study lists 2 primary outcomes in all. 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 11 Jun 2018.