KeratoconusNCT04918316
Initial Correction Keratoconus
A study testing Corneal gas permeable lens in people with Keratoconus, run by University of Illinois at Chicago at 4 sites in United States.
Trial summary
Keratoconus is a non-inflammatory, progressive disease in which corneal irregularity increases. As the condition develops, more advanced forms of optical correction are needed to improve vision for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal gas permeable lens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Jul 2021to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of keratoconus
- Available baseline corneal topography and pachymetry
- Amsler-Krumeich keratoconus classification9 of stage 1
Who cannot join
- No prior corneal transplantation or INTACTS
- No prior use of hybrid, corneal or scleral gas permeable lenses
- Presence of corneal scarring.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Illinois at Chicago Eye and Ear Infirmary
Chicago, Illinois, 60612
Illinois Eye Institute
Chicago, Illinois, 60616
The Ohio State University College of Optometry
Columbus, Ohio, 43210
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Initial Correction Keratoconus: Scleral vs Corneal Gas Permeable Lenses SCOPE Study
Keratoconus is a non-inflammatory, progressive disease in which corneal irregularity increases. As the condition develops, more advanced forms of optical correction are needed to improve vision for patients. Until recently, small diameter corneal gas permeable lenses were considered the primary mode of correction for patients with keratoconus. Now, however, practitioners have multiple options for reducing the optical aberrations caused by keratoconus, including scleral lenses. As of yet, no single option for optical correction has been identified as the preferred mode of correction in terms of overall patient satisfaction with vision, comfort, and ease of use. The order in which various forms of optical correction would be most logically introduced has yet to be determined. This is a study comparing small diameter corneal gas permeable and large diameter scleral lenses in individuals with keratoconus.
This study will prospectively compare visual satisfaction and ease of use between corneal gas permeable and scleral lenses for patients with mild to moderate keratoconus.
Read the detailed description
While both corneal gas permeable and scleral lenses have been show to improve visual acuity in individuals with keratoconus, it has yet to be determined if one option has superior comfort and overall patient satisfaction in patients new to gas permeable lens use. In this study, patients will be prospectively fit with both corneal gas permeable and scleral lenses according to standard clinical practice. Both corneal gas permeable and scleral lenses are considered standard of care for patients with keratoconus.
The investigators hypothesize that study participants will select scleral lens over corneal gas permeable lens as their preferred final lens type of choice.
The Primary outcome measure of this study is participant selected final lens choice for continued use for the management of keratoconus.
Methods:
Study Design This is a prospective, multi-center, randomized interventional clinical trial with a 2x2 crossover design of patients with keratoconus fit with corneal and scleral gas permeable contact lenses. The crossover design allows intra-subject differences between two randomized groups with participants serving as their own controls. Contact lens #1 will be the SynergEyes VS (Synergeyes, Inc., Carlsbad CA) which features bi-tangential toric peripheries with linear landing zones. The standard lens is 16.0mm and is available from 14.5 to 17.5mm diameters. Contact lens #2 will be the RoseK2 corneal gas permeable lens (Blanchard Contact Lens, Inc. Manchester, NH). The lens is available in with a base curve range from 4.30 to 8.60 mm, diameter of 7.90 to 10.40mm.
Inclusion Criteria
- Age 18 or older.
- Diagnosis of keratoconus.
- Available baseline corneal topography and pachymetry
- Amsler-Krumeich keratoconus classification of stage 1 or higher
Exclusion Criteria
- No prior corneal transplantation or INTACTS
- No prior use of hybrid, corneal or scleral gas permeable lenses
- Presence of corneal scarring
Study procedures During the initial study visits patient demographics, past ocular and medical history and best corrected visual acuity with manifest refraction will be recorded. Additional testing may include corneal topography, pachymetry and meibography. Dry eye symptoms and contact lens comfort will be assessed using the OSDI and CLDEQ questionnaires.
Participants will be fit according to standard practices with the RoseK 2 corneal gas permeable and Synergeyes VS scleral lenses following manufacturer's recommendations. Over refraction and best corrected visual acuity will be recorded. Subjective comfort with lens use rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
Participants will be randomized to dispense lens #1 vs lens #2. They will be trained in safe application and removal and provided instructions on lens disinfection procedures. Best corrected visual acuity with lens #1 and subjective comfort with lens use will be rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
At the next visit, participants will return wearing lens #1 for minimum of 3 hours. Best corrected visual acuity with lens #1 will be recorded as well as hours of lens wear today, average hours of lens wear time, days per week of per week and daily time spent on lens application and removal. They will rate subjective comfort with lens use on comfort scale of 0 (not comfortable) to 10 (very comfortable). Dry eye symptoms will be assessed using OSDI and CLDEQ questionnaires. Participants will be trained in application and removal with lens #2. Best corrected visual acuity with lens #2 and subjective comfort will be rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
At the final visit, participants will return wearing lens #2 for minimum of 3 hours. Best corrected visual acuity with lens #2 will be recorded as well as hours of lens wear today, average hours of lens wear time, days per week of per week and daily time spent on lens application and removal. They will rate subjective comfort with lens use on comfort scale of 0 (not comfortable) to 10 (very comfortable). Dry eye symptoms will be assessed using OSDI and CLDEQ questionnaires. Participants will be trained in application and removal with lens #2. Best corrected visual acuity with lens #2 and subjective comfort will be rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
The participant will make a final selection of lens of choice #1 or #2.
- Conditions
- Keratoconus
- Being tested
- Corneal gas permeable lens
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal gas permeable lensOther
Fit in corneal gas permeable contact lens first.
| Study group | Role | What they receive |
|---|---|---|
| Corneal gas permeable lens first | Active comparator | Device: corneal gas permeable contact lenses (RoseK2 corneal Blanchard Contact Lens, Inc. Manchester, NH).
Participants with an odd study ID will be fit with the corneal gas permeable lens first. Receives: Other: Corneal gas permeable lens |
| Scleral lens first | Active comparator | Device: scleral lenses (SynergEyes VS (Synergeyes, Inc., Carlsbad CA).
Participants with an even study ID will be fit with the scleral lens first. Receives: Other: Corneal gas permeable lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final contact lens choice
Each study participant will select whether to continue with Lens 1 or Lens 2. The percentage of those who choose a Scleral Lens will be compared to the percentage of participants who select corneal gas permeable lenses.
Measured: At study completion (6-24 weeks)
Secondary outcomes (1)
Subjective comfort with lens use
Subjective comfort with lens use will be rated by participants on comfort scale of 0 (not comfortable) to 10 (very comfortable).
Measured: Baseline, Study Visit 1 (2-4 weeks), Study Visit 2 (4-10 weeks) and at study completion (6-24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start23 Jul 2021
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Sep 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen S Shorter, University of Illinois at Chicago
- Investigators
- Ellen S Shorter, OD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918316
- Sponsor's protocol ID
- 2020-1504
- Status last verified
- Jan 2025
- First submitted
- 14 May 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Correction Keratoconus: Scleral vs Corneal Gas Permeable Lenses SCOPE Study
- ClinicalTrials.gov ID
- NCT04918316
- Acronym / sponsor ID
- 2020-1504
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Jun 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.
Keratoconus is a non-inflammatory, progressive disease in which corneal irregularity increases. As the condition develops, more advanced forms of optical correction are needed to improve vision for patients. Until recently, small diameter corneal gas permeable lenses were considered the primary mode of correction for patients with keratoconus. Now, however, practitioners have multiple options for reducing the optical aberrations caused by keratoconus, including scleral lenses. As of yet, no single option for optical correction has been identified as the preferred mode of correction in terms of overall patient satisfaction with vision, comfort, and ease of use. The order in which various forms of optical correction would be most logically introduced has yet to be determined. This is a study comparing small diameter corneal gas permeable and large diameter scleral lenses in individuals with keratoconus.
This study will prospectively compare visual satisfaction and ease of use between corneal gas permeable and scleral lenses for patients with mild to moderate keratoconus.
Detailed description
While both corneal gas permeable and scleral lenses have been show to improve visual acuity in individuals with keratoconus, it has yet to be determined if one option has superior comfort and overall patient satisfaction in patients new to gas permeable lens use. In this study, patients will be prospectively fit with both corneal gas permeable and scleral lenses according to standard clinical practice. Both corneal gas permeable and scleral lenses are considered standard of care for patients with keratoconus.
The investigators hypothesize that study participants will select scleral lens over corneal gas permeable lens as their preferred final lens type of choice.
The Primary outcome measure of this study is participant selected final lens choice for continued use for the management of keratoconus.
Methods:
Study Design This is a prospective, multi-center, randomized interventional clinical trial with a 2x2 crossover design of patients with keratoconus fit with corneal and scleral gas permeable contact lenses. The crossover design allows intra-subject differences between two randomized groups with participants serving as their own controls. Contact lens #1 will be the SynergEyes VS (Synergeyes, Inc., Carlsbad CA) which features bi-tangential toric peripheries with linear landing zones. The standard lens is 16.0mm and is available from 14.5 to 17.5mm diameters. Contact lens #2 will be the RoseK2 corneal gas permeable lens (Blanchard Contact Lens, Inc. Manchester, NH). The lens is available in with a base curve range from 4.30 to 8.60 mm, diameter of 7.90 to 10.40mm.
Inclusion Criteria
- Age 18 or older.
- Diagnosis of keratoconus.
- Available baseline corneal topography and pachymetry
- Amsler-Krumeich keratoconus classification of stage 1 or higher
Exclusion Criteria
- No prior corneal transplantation or INTACTS
- No prior use of hybrid, corneal or scleral gas permeable lenses
- Presence of corneal scarring
Study procedures During the initial study visits patient demographics, past ocular and medical history and best corrected visual acuity with manifest refraction will be recorded. Additional testing may include corneal topography, pachymetry and meibography. Dry eye symptoms and contact lens comfort will be assessed using the OSDI and CLDEQ questionnaires.
Participants will be fit according to standard practices with the RoseK 2 corneal gas permeable and Synergeyes VS scleral lenses following manufacturer's recommendations. Over refraction and best corrected visual acuity will be recorded. Subjective comfort with lens use rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
Participants will be randomized to dispense lens #1 vs lens #2. They will be trained in safe application and removal and provided instructions on lens disinfection procedures. Best corrected visual acuity with lens #1 and subjective comfort with lens use will be rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
At the next visit, participants will return wearing lens #1 for minimum of 3 hours. Best corrected visual acuity with lens #1 will be recorded as well as hours of lens wear today, average hours of lens wear time, days per week of per week and daily time spent on lens application and removal. They will rate subjective comfort with lens use on comfort scale of 0 (not comfortable) to 10 (very comfortable). Dry eye symptoms will be assessed using OSDI and CLDEQ questionnaires. Participants will be trained in application and removal with lens #2. Best corrected visual acuity with lens #2 and subjective comfort will be rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
At the final visit, participants will return wearing lens #2 for minimum of 3 hours. Best corrected visual acuity with lens #2 will be recorded as well as hours of lens wear today, average hours of lens wear time, days per week of per week and daily time spent on lens application and removal. They will rate subjective comfort with lens use on comfort scale of 0 (not comfortable) to 10 (very comfortable). Dry eye symptoms will be assessed using OSDI and CLDEQ questionnaires. Participants will be trained in application and removal with lens #2. Best corrected visual acuity with lens #2 and subjective comfort will be rated on comfort scale of 0 (not comfortable) to 10 (very comfortable).
The participant will make a final selection of lens of choice #1 or #2.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corneal gas permeable lens first | Active comparator | Other: Corneal gas permeable lensDevice: corneal gas permeable contact lenses (RoseK2 corneal Blanchard Contact Lens, Inc. Manchester, NH). Participants with an odd study ID will be fit with the corneal gas permeable lens first. |
| Scleral lens first | Active comparator | Other: Corneal gas permeable lensDevice: scleral lenses (SynergEyes VS (Synergeyes, Inc., Carlsbad CA). Participants with an even study ID will be fit with the scleral lens first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of keratoconus
- Available baseline corneal topography and pachymetry
- Amsler-Krumeich keratoconus classification9 of stage 1
Key exclusion criteria (3 listed)
- No prior corneal transplantation or INTACTS
- No prior use of hybrid, corneal or scleral gas permeable lenses
- Presence of corneal scarring.
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 |
|---|---|---|
| Corneal gas permeable lensFit in corneal gas permeable contact lens first. | Other | Corneal gas permeable lens first, Scleral lens first |
Primary outcome
Final contact lens choice
Time frame: At study completion (6-24 weeks)
Each study participant will select whether to continue with Lens 1 or Lens 2. The percentage of those who choose a Scleral Lens will be compared to the percentage of participants who select corneal gas permeable lenses.
1 secondary outcome
Subjective comfort with lens use
Time frame: Baseline, Study Visit 1 (2-4 weeks), Study Visit 2 (4-10 weeks) and at study completion (6-24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Ellen S Shorter, OD principal investigator
University of Illinois at Chicago
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal gas permeable lens in people with Keratoconus, run by University of Illinois at Chicago at 4 sites 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Final contact lens choice (time frame: At study completion (6-24 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 22 Jan 2025.