Treatment of Keratoconus With Advanced Corneal Crosslinking
Primary Purpose
Keratoconus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corneal reshaping/crosslinking (CRXL)
Corneal Crosslinking (CXL)
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Corneal crosslinking, Corneal biomechanics, Corneal densitometry, Scheimpflug photography
Eligibility Criteria
Inclusion Criteria:
- Patients planned for corneal crosslinking.
- Progressive keratoconus documented with Scheimpflug photography using the Pentacam Scheimflug camera and/or repeated subjective refraction and keratometry.
- A keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" KC quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires.
- Minimum corneal thickness of 400 µm at the thinnest point after epithelial removal.
- 18-28 years of age
- No ocular abnormalities except keratoconus
- No previous ocular surgery
- No cognitive insufficiency interfering with the informed consent.
Exclusion Criteria:
- Age under 18 or over 28
- Any corneal abnormalities except keratoconus
- Previous ocular surgery
- Cognitive insufficiency.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
No Intervention
No Intervention
Arm Label
Corneal reshaping/crosslinking (CRXL)
Corneal crosslinking (CXL)
Control group to CRXL
Control group to CXL
Arm Description
Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment.
Standard corneal crosslinking using the Dresden protocol.
Healthy subjects, age- and sex-matched to the CRXL group.
Healthy subjects, age- and sex-matched to the CXL group.
Outcomes
Primary Outcome Measures
Change from baseline in refraction
Refractive errors, including lower and higher order aberrations in the cornea
Secondary Outcome Measures
Change from baseline in ETDRS LogMAR visual acuity
Uncorrected and best spectacle corrected visual acuity measured with the Early treatment diabetic retinopathy study, graded in logarithmic values of the minimal angle of resolution
Change from baseline in corneal biomechanical stability measured with ORA
Biomechanical stability assessed with the ocular response analyzer
Change from baseline in corneal biomechanical stability measured with ART
Biomechanical stability assessed with the applanation resonance tonometer
Change from baseline in corneal biomechanical stability measured with GAT
Biomechanical stability assessed with the Goldmann applanation tonometer
Change from baseline in corneal densitometry
Corneal light reflectivity (back scatter) assessed with the Pentacam HR Scheimpflug camera
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02425150
Brief Title
Treatment of Keratoconus With Advanced Corneal Crosslinking
Official Title
Treatment of Keratoconus With Advanced Corneal Crosslinking
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to determine whether mechanical compression of the cornea during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve the optical outcomes of the treatment.
Detailed Description
The study is designed as a prospective, open, randomized controlled trial involving patients aged 18-28 years of both genders with uni- or bilateral keratoconus planned for routine corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 30+30 eyes with keratoconus, which are randomized to receive either conventional corneal crosslinking (n=30) using the Dresden protocol or a modified treatment - corneal reshaping and crosslinking (n=30), where a rigid contact lens is sutured to the cornea during the treatment to flatten the corneal curvature and potentially improve the optical outcome after the treatment. Patients are randomized utilizing a list of unique random numbers between 1 and 60. All patients are informed about the procedures before consenting to participate in the study. The study also involves 60 eyes of healthy age- and sex-matched control subjects.
At baseline, before treatment, each eye is evaluated with autorefractometer measurement, best spectacle-corrected LogMAR visual acuity, Pentacam Scheimpflug photography, Goldmann applanation tonometry and biomicroscopy. The corneal biomechanical characteristics are assessed with applanation resonance tonometry and the ocular response analyzer. The investigations are repeated at 1 month, 6 months, 2 years and 5 years after the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Corneal crosslinking, Corneal biomechanics, Corneal densitometry, Scheimpflug photography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corneal reshaping/crosslinking (CRXL)
Arm Type
Experimental
Arm Description
Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment.
Arm Title
Corneal crosslinking (CXL)
Arm Type
Active Comparator
Arm Description
Standard corneal crosslinking using the Dresden protocol.
Arm Title
Control group to CRXL
Arm Type
No Intervention
Arm Description
Healthy subjects, age- and sex-matched to the CRXL group.
Arm Title
Control group to CXL
Arm Type
No Intervention
Arm Description
Healthy subjects, age- and sex-matched to the CXL group.
Intervention Type
Procedure
Intervention Name(s)
Corneal reshaping/crosslinking (CRXL)
Intervention Description
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
Intervention Type
Procedure
Intervention Name(s)
Corneal Crosslinking (CXL)
Intervention Description
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
Primary Outcome Measure Information:
Title
Change from baseline in refraction
Description
Refractive errors, including lower and higher order aberrations in the cornea
Time Frame
1, 6, 24 and 60 months after the treatment
Secondary Outcome Measure Information:
Title
Change from baseline in ETDRS LogMAR visual acuity
Description
Uncorrected and best spectacle corrected visual acuity measured with the Early treatment diabetic retinopathy study, graded in logarithmic values of the minimal angle of resolution
Time Frame
1, 6, 24 and 60 months after the treatment
Title
Change from baseline in corneal biomechanical stability measured with ORA
Description
Biomechanical stability assessed with the ocular response analyzer
Time Frame
1, 6, 24 and 60 months after the treatment
Title
Change from baseline in corneal biomechanical stability measured with ART
Description
Biomechanical stability assessed with the applanation resonance tonometer
Time Frame
1, 6, 24 and 60 months after the treatment
Title
Change from baseline in corneal biomechanical stability measured with GAT
Description
Biomechanical stability assessed with the Goldmann applanation tonometer
Time Frame
1, 6, 24 and 60 months after the treatment
Title
Change from baseline in corneal densitometry
Description
Corneal light reflectivity (back scatter) assessed with the Pentacam HR Scheimpflug camera
Time Frame
1, 6, 24 and 60 months after the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients planned for corneal crosslinking.
Progressive keratoconus documented with Scheimpflug photography using the Pentacam Scheimflug camera and/or repeated subjective refraction and keratometry.
A keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" KC quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires.
Minimum corneal thickness of 400 µm at the thinnest point after epithelial removal.
18-28 years of age
No ocular abnormalities except keratoconus
No previous ocular surgery
No cognitive insufficiency interfering with the informed consent.
Exclusion Criteria:
Age under 18 or over 28
Any corneal abnormalities except keratoconus
Previous ocular surgery
Cognitive insufficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Behndig, Professor
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24628999
Citation
Beckman Rehnman J, Behndig A, Hallberg P, Linden C. Initial results from mechanical compression of the cornea during crosslinking for keratoconus. Acta Ophthalmol. 2014 Nov;92(7):644-9. doi: 10.1111/aos.12380. Epub 2014 Mar 15.
Results Reference
background
PubMed Identifier
25171564
Citation
Beckman Rehnman J, Behndig A, Hallberg P, Linden C. Increased corneal hysteresis after corneal collagen crosslinking: a study based on applanation resonance technology. JAMA Ophthalmol. 2014 Dec;132(12):1426-32. doi: 10.1001/jamaophthalmol.2014.3029.
Results Reference
background
PubMed Identifier
21873026
Citation
Beckman Rehnman J, Janbaz CC, Behndig A, Linden C. Spatial distribution of corneal light scattering after corneal collagen crosslinking. J Cataract Refract Surg. 2011 Nov;37(11):1939-44. doi: 10.1016/j.jcrs.2011.05.028. Epub 2011 Aug 27.
Results Reference
result
PubMed Identifier
26312777
Citation
Rehnman JB, Linden C, Hallberg P, Behndig A. Treatment Effect and Corneal Light Scattering With 2 Corneal Cross-linking Protocols: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Nov;133(11):1254-60. doi: 10.1001/jamaophthalmol.2015.2852.
Results Reference
derived
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Treatment of Keratoconus With Advanced Corneal Crosslinking
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