KeratoconusNCT02425150
Treatment of Keratoconus With Advanced Corneal Crosslinking
A study testing Corneal reshaping/crosslinking (CRXL) and Corneal Crosslinking (CXL) in people with Keratoconus, run by Umeå University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal reshaping/crosslinking (CRXL) and Corneal Crosslinking (CXL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 2014
- 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 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Age under 18 or over 28
- Any corneal abnormalities except keratoconus
- Previous ocular surgery
- Cognitive insufficiency.
About this study
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.
Read the 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.
- Conditions
- Keratoconus
- Being tested
- Corneal reshaping/crosslinking (CRXL), Corneal Crosslinking (CXL)
- Keywords
- Keratoconus, Corneal crosslinking, Corneal biomechanics, Corneal densitometry, Scheimpflug photography
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal reshaping/crosslinking (CRXL)Procedure or surgery
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.
Corneal Crosslinking (CXL)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Corneal reshaping/crosslinking (CRXL) | Experimental | Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment. Receives: Procedure: Corneal reshaping/crosslinking (CRXL) |
| Corneal crosslinking (CXL) | Active comparator | Standard corneal crosslinking using the Dresden protocol. Receives: Procedure: Corneal Crosslinking (CXL) |
| Control group to CRXL | No intervention | Healthy subjects, age- and sex-matched to the CRXL group. |
| Control group to CXL | No intervention | Healthy subjects, age- and sex-matched to the CXL group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in refraction
Refractive errors, including lower and higher order aberrations in the cornea
Measured: 1, 6, 24 and 60 months after the treatment
Secondary outcomes (5)
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
Measured: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ORA
Biomechanical stability assessed with the ocular response analyzer
Measured: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ART
Biomechanical stability assessed with the applanation resonance tonometer
Measured: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with GAT
Biomechanical stability assessed with the Goldmann applanation tonometer
Measured: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal densitometry
Corneal light reflectivity (back scatter) assessed with the Pentacam HR Scheimpflug camera
Measured: 1, 6, 24 and 60 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startOct 2009
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Behndig, Umeå University
- Investigators
- Anders Behndig, Professor, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425150
- Sponsor's protocol ID
- CRXL
- Status last verified
- Dec 2020
- First submitted
- 13 Apr 2015
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24628999Beckman 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.
PubMed 25171564Beckman 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.
PubMed 21873026Rehnman 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.
PubMed 26312777
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Keratoconus With Advanced Corneal Crosslinking
- ClinicalTrials.gov ID
- NCT02425150
- Acronym / sponsor ID
- CRXL
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Corneal crosslinking, Corneal biomechanics, Corneal densitometry, Scheimpflug photography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Apr 2015 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Corneal reshaping/crosslinking (CRXL) | Experimental | Procedure: Corneal reshaping/crosslinking (CRXL)Corneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment. |
| Corneal crosslinking (CXL) | Active comparator | Procedure: Corneal Crosslinking (CXL)Standard corneal crosslinking using the Dresden protocol. |
| Control group to CRXL | No intervention | –Healthy subjects, age- and sex-matched to the CRXL group. |
| Control group to CXL | No intervention | –Healthy subjects, age- and sex-matched to the CXL group. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Age under 18 or over 28
- Any corneal abnormalities except keratoconus
- Previous ocular surgery
- Cognitive insufficiency.
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 reshaping/crosslinking (CRXL)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. | Procedure or surgery | Corneal reshaping/crosslinking (CRXL) |
| Corneal Crosslinking (CXL)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. | Procedure or surgery | Corneal crosslinking (CXL) |
Primary outcome
Change from baseline in refraction
Time frame: 1, 6, 24 and 60 months after the treatment
Refractive errors, including lower and higher order aberrations in the cornea
5 secondary outcomes
Change from baseline in ETDRS LogMAR visual acuity
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ORA
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ART
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with GAT
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal densitometry
Time frame: 1, 6, 24 and 60 months after the treatment
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 Dec 2020.
- Background: PubMed 24628999Beckman 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.
- Background: PubMed 25171564Beckman 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 publication: PubMed 21873026Beckman 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.
- Derived from this study: PubMed 26312777Rehnman 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.
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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.
Anders Behndig, Professor principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
A study testing Corneal reshaping/crosslinking (CRXL) and Corneal Crosslinking (CXL) in people with Keratoconus, run by Umeå University.
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 8 inclusion and 4 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in refraction (time frame: 1, 6, 24 and 60 months after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02425150, which also lists 4 linked publications.
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 Dec 2020.