KeratoconusWFG ScleralsNCT04698590
Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism
A study testing Wavefront Guided Scleral Lenses and Traditional Scleral Lenses in people with Keratoconus and Irregular Astigmatism, run by Cornea and Laser Eye Institute at 1 site in United States.
Trial summary
Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Irregular Astigmatism, Corneal Ectasia
- What is being tested?
- Wavefront Guided Scleral Lenses and Traditional Scleral Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 31 Dec 2025
- 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
- -A diagnosis of keratoconus or irregular astigmatism
Who cannot join
- Patients with other visually significant ocular pathology.
- Inability to apply or remove a scleral lens.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornea and Laser Eye Institue - Hersh Vision Group
Teaneck, New Jersey, 07666
About this study
Official title: Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus or Irregular Astigmatism
Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (HOA). HOA's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. Specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing HOA's and improving vision. In many patients the resultant vision, though improved, still has some level of residual HOA's affecting the quality of vision. Custom scleral lenses with customized wavefront guided optics can be used to reduce residual HOA's and improve vision further. These lenses have been referred to as higher order aberration correcting scleral lenses or HOA correcting sclerals and wavefront guided scleral lenses or WFG sclerals.
Read the detailed description
The purpose of this study is to investigate the effect of an advanced technique for designing custom scleral contact lenses to further improve vision in keratoconus or irregular astigmatism by reducing residual aberrations. The derived custom scleral lenses will include customized aberration correcting optics, guided by a wavefront aberrometer measurements. These lenses are custom made based on the individual measurements from an eye.The primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. In particular, the investigators will compare efficacy in reducing aberrations and improvement in vision.
- Conditions
- Keratoconus, Irregular Astigmatism, Corneal Ectasia, Aberration, Corneal Wavefront, Wavefront Aberration, Corneal, Pellucid Marginal Corneal Degeneration
- Being tested
- Wavefront Guided Scleral Lenses, Traditional Scleral Lenses
- Keywords
- Scleral lenses, Scleral lens, Wavefront guided scleral lenses, Higher order aberrations, HOA scleral lenses, Sclerals, Higher order aberration correction, Custom scleral lenses, Wavefront guided, Keratoconus, Irregular Astigmatism, WFG scleral lenses
- Medical subject headings
- Keratoconus, Corneal Wavefront Aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wavefront Guided Scleral LensesDevice
Also called ARES Scleral Lenses
Custom wavefront guided, higher order aberration correcting scleral lenses
Traditional Scleral LensesDevice
Also called CS Scleral Lenses
Traditional scleral lenses
| Study group | Role | What they receive |
|---|---|---|
| WFG Scleral Lenses | Active comparator | Scleral lenses with customized wavefront guided optics Receives: Device: Wavefront Guided Scleral Lenses |
| Traditional Scleral Lenses | Placebo comparator | Scleral lenses with traditional optics Receives: Device: Traditional Scleral Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher order aberration
Total higher order aberrations with traditional scleral lenses will be compared with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in total higher order aberrations with wavefront guided scleral lenses from dispense to 4 week follow up, will be evaluated.
Measured: 4 weeks
Secondary outcomes (2)
Visual Acuity
Visual acuity with traditional scleral lenses will be compared to visual acuity with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in visual acuity from dispense to 4 week follow up, will be evaluated for signs of neural adaptation.
Measured: 4 weeks
Contrast Sensitivity
Contrast sensitivity with traditional scleral lenses will be compared to contrast sensitivity with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in contrast sensitivity with wavefront guided scleral lenses from dispense to 4 week follow up, will be evaluated for signs of neural adaptation.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start15 Jan 2021
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Dec 2025 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornea and Laser Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John D Gelles, OD, Principal investigator, The Cornea and Laser Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698590
- Sponsor's protocol ID
- CLEI WFG Scleral Lens
- Acronym
- WFG Sclerals
- Status last verified
- May 2024
- First submitted
- 31 Dec 2020
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus or Irregular Astigmatism
- ClinicalTrials.gov ID
- NCT04698590
- Acronym / sponsor ID
- WFG Sclerals / CLEI WFG Scleral Lens
- Conditions
- Keratoconus, Irregular Astigmatism, Corneal Ectasia, Aberration, Corneal Wavefront, Wavefront Aberration, Corneal, Pellucid Marginal Corneal Degeneration
- Keywords
- Scleral lenses, Scleral lens, Wavefront guided scleral lenses, Higher order aberrations, HOA scleral lenses, Sclerals, Higher order aberration correction, Custom scleral lenses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cornea and Laser Eye InstituteUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jan 2021 (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.
Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (HOA). HOA's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. Specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing HOA's and improving vision. In many patients the resultant vision, though improved, still has some level of residual HOA's affecting the quality of vision. Custom scleral lenses with customized wavefront guided optics can be used to reduce residual HOA's and improve vision further. These lenses have been referred to as higher order aberration correcting scleral lenses or HOA correcting sclerals and wavefront guided scleral lenses or WFG sclerals.
Detailed description
The purpose of this study is to investigate the effect of an advanced technique for designing custom scleral contact lenses to further improve vision in keratoconus or irregular astigmatism by reducing residual aberrations. The derived custom scleral lenses will include customized aberration correcting optics, guided by a wavefront aberrometer measurements. These lenses are custom made based on the individual measurements from an eye.The primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. In particular, the investigators will compare efficacy in reducing aberrations and improvement in vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WFG Scleral Lenses | Active comparator | Device: Wavefront Guided Scleral LensesScleral lenses with customized wavefront guided optics |
| Traditional Scleral Lenses | Placebo comparator | Device: Traditional Scleral LensesScleral lenses with traditional optics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -A diagnosis of keratoconus or irregular astigmatism
Key exclusion criteria (2 listed)
- Patients with other visually significant ocular pathology.
- Inability to apply or remove a scleral lens.
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 |
|---|---|---|
| Wavefront Guided Scleral LensesAlso: ARES Scleral LensesCustom wavefront guided, higher order aberration correcting scleral lenses | Device | WFG Scleral Lenses |
| Traditional Scleral LensesAlso: CS Scleral LensesTraditional scleral lenses | Device | Traditional Scleral Lenses |
Primary outcome
Higher order aberration
Time frame: 4 weeks
Total higher order aberrations with traditional scleral lenses will be compared with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in total higher order aberrations with wavefront guided scleral lenses from dispense to 4 week follow up, will be evaluated.
2 secondary outcomes
Visual Acuity
Time frame: 4 weeks
Contrast Sensitivity
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
John D Gelles, OD principal investigator
The Cornea and Laser Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wavefront Guided Scleral Lenses and Traditional Scleral Lenses in people with Keratoconus and Irregular Astigmatism, run by Cornea and Laser Eye Institute at 1 site in United States.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 May 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 States. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Higher order aberration (time frame: 4 weeks). 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 3 May 2024.