Initial Correction Keratoconus
Primary Purpose
Keratoconus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Corneal gas permeable lens
Sponsored by
About this trial
This is an interventional other trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of keratoconus
- Available baseline corneal topography and pachymetry
- Amsler-Krumeich keratoconus classification9 of stage 1
Exclusion Criteria:
- No prior corneal transplantation or INTACTS
- No prior use of hybrid, corneal or scleral gas permeable lenses
- Presence of corneal scarring.
Sites / Locations
- University of Illinois at Chicago Eye and Ear InfirmaryRecruiting
- Illinois Eye InstituteRecruiting
- Mayo ClinicRecruiting
- The Ohio State University College of OptometryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Corneal gas permeable lens first
Scleral lens first
Arm Description
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.
Device: scleral lenses (SynergEyes VS (Synergeyes, Inc., Carlsbad CA). Participants with an even study ID will be fit with the scleral lens first.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT04918316
First Posted
May 14, 2021
Last Updated
May 18, 2022
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04918316
Brief Title
Initial Correction Keratoconus
Official Title
Initial Correction Keratoconus: Scleral vs Corneal Gas Permeable Lenses SCOPE Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corneal gas permeable lens first
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Scleral lens first
Arm Type
Active Comparator
Arm Description
Device: scleral lenses (SynergEyes VS (Synergeyes, Inc., Carlsbad CA).
Participants with an even study ID will be fit with the scleral lens first.
Intervention Type
Other
Intervention Name(s)
Corneal gas permeable lens
Intervention Description
Fit in corneal gas permeable contact lens first.
Primary Outcome Measure Information:
Title
Final contact lens choice
Description
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.
Time Frame
At study completion (6-24 weeks)
Secondary Outcome Measure Information:
Title
Subjective comfort with lens use
Description
Subjective comfort with lens use will be rated by participants on comfort scale of 0 (not comfortable) to 10 (very comfortable).
Time Frame
Baseline, Study Visit 1 (2-4 weeks), Study Visit 2 (4-10 weeks) and at study completion (6-24 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of keratoconus
Available baseline corneal topography and pachymetry
Amsler-Krumeich keratoconus classification9 of stage 1
Exclusion Criteria:
No prior corneal transplantation or INTACTS
No prior use of hybrid, corneal or scleral gas permeable lenses
Presence of corneal scarring.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen S Shorter, OD
Phone
312-996-5410
Email
eshorter@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bhavana Kolli, MHA
Phone
312-996-7182
Email
bkolli2@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen S Shorter, OD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago Eye and Ear Infirmary
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Shorter, OD
Phone
312-996-5410
Email
eshorter@uic.edu
Facility Name
Illinois Eye Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Harthan, OD
First Name & Middle Initial & Last Name & Degree
Jennifer Harthan, OD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherie Nau, OD
First Name & Middle Initial & Last Name & Degree
Cherie Nau, OD
First Name & Middle Initial & Last Name & Degree
Muriel Schornack, OD
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Fogt, OD, MS
First Name & Middle Initial & Last Name & Degree
Jennifer Fogt, OD, MS
12. IPD Sharing Statement
Plan to Share IPD
No
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Initial Correction Keratoconus
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