KeratoconusNCT06264024
Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
A study testing Corneal collagen cross linking (CXL) and Transepithelial phototherapeutic keratectomy (t-PTK) in people with Keratoconus, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK. The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe. 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 collagen cross linking (CXL) and Transepithelial phototherapeutic keratectomy (t-PTK)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteNorway
- Study dates
- 12 Feb 2024to 1 Feb 2034
- 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
- Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit.
- Progressive keratoconus with indication for CXL
- Corneal thickness ≥ 420 μm
Who cannot join
- Other eye disease causing visual impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Ophhtalmology, University of Oslo
Oslo
Olav Kristianslund, MD, PhD, olakri@ous-hf.no
Bjarne L Thorbjørnsen, MD, uxtbja@ous-hf.no
About this study
The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.
The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.
- Conditions
- Keratoconus
- Being tested
- Corneal collagen cross linking (CXL), Transepithelial phototherapeutic keratectomy (t-PTK)
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal collagen cross linking (CXL)Procedure or surgery
Use of Avedro Inc. KXL 1 system to stop progression of keratoconus
Transepithelial phototherapeutic keratectomy (t-PTK)Procedure or surgery
Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex
| Study group | Role | What they receive |
|---|---|---|
| CXL | Active comparator | Treatment with CXL alone Receives: Procedure: Corneal collagen cross linking (CXL) |
| CXL and t-PTK | Experimental | Treatment with t-PTK combined with CXL Receives: Procedure: Corneal collagen cross linking (CXL); Procedure: Transepithelial phototherapeutic keratectomy (t-PTK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Measured: 1 month after surgery
Risk of progression
Change in keratometric values
Measured: 1 year after surgery
Secondary outcomes (16)
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Measured: 3 month after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Measured: 6 month after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Measured: 1 year after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Measured: 2 years after surgery
Visual acuity
Uncorrected and corrected distance visual acuity in logMAR
Measured: 5 years after surgery
Risk of progression
Change in keratometric values
Measured: 1 month after surgery
Risk of progression
Change in keratometric values
Measured: 3 months after surgery
Risk of progression
Change in keratometric values
Measured: 6 months after surgery
Risk of progression
Change in keratometric values
Measured: 2 years after surgery
Risk of progression
Change in keratometric values
Measured: 5 years after surgery
Depth of demarcation line (OCT)
Measured with corneal optical coherence tomography (OCT)
Measured: 1 month after surgery
Depth of demarcation line (confocal microscopy)
Measured with confocal microscopy
Measured: 1 month after surgery
Patient reported outcome measure (PROMs)
National eye institute Visual Function Questionnaire 25
Measured: 1 month after surgery
Patient reported outcome measure (PROMs)
National eye institute Visual Function Questionnaire 25
Measured: 6 months after surgery
Patient reported outcome measure (PROMs)
National eye institute Visual Function Questionnaire 25
Measured: 2 years after surgery
Patient reported pain after surgery
Pain the first 48 hours after the surgery graded on visual analogue scale (VAS); 0 to 10 cm.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start12 Feb 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Feb 2034 (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.
- More trials run by Oslo University HospitalThe 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
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olav Kristianslund, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264024
- Sponsor's protocol ID
- 519516
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
- ClinicalTrials.gov ID
- NCT06264024
- Acronym / sponsor ID
- 519516
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 12 Feb 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 16 Feb 2024 (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.
The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.
The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CXL | Active comparator | Procedure: Corneal collagen cross linking (CXL)Treatment with CXL alone |
| CXL and t-PTK | Experimental | Procedure: Corneal collagen cross linking (CXL), Procedure: Transepithelial phototherapeutic keratectomy (t-PTK)Treatment with t-PTK combined with CXL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit.
- Progressive keratoconus with indication for CXL
- Corneal thickness ≥ 420 μm
Key exclusion criteria (1 listed)
- Other eye disease causing visual impairment
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 collagen cross linking (CXL)Use of Avedro Inc. KXL 1 system to stop progression of keratoconus | Procedure or surgery | CXL, CXL and t-PTK |
| Transepithelial phototherapeutic keratectomy (t-PTK)Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex | Procedure or surgery | CXL and t-PTK |
Primary outcome
Visual acuity
Time frame: 1 month after surgery
Uncorrected and corrected distance visual acuity in logMAR
Risk of progression
Time frame: 1 year after surgery
Change in keratometric values
16 secondary outcomes
Visual acuity
Time frame: 3 month after surgery
Visual acuity
Time frame: 6 month after surgery
Visual acuity
Time frame: 1 year after surgery
Visual acuity
Time frame: 2 years after surgery
Visual acuity
Time frame: 5 years after surgery
Risk of progression
Time frame: 1 month after surgery
Risk of progression
Time frame: 3 months after surgery
Risk of progression
Time frame: 6 months after surgery
Risk of progression
Time frame: 2 years after surgery
Risk of progression
Time frame: 5 years after surgery
Depth of demarcation line (OCT)
Time frame: 1 month after surgery
Depth of demarcation line (confocal microscopy)
Time frame: 1 month after surgery
Patient reported outcome measure (PROMs)
Time frame: 1 month after surgery
Patient reported outcome measure (PROMs)
Time frame: 6 months after surgery
Patient reported outcome measure (PROMs)
Time frame: 2 years after surgery
Patient reported pain after surgery
Time frame: 48 hours after surgery
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 16 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal collagen cross linking (CXL) and Transepithelial phototherapeutic keratectomy (t-PTK) in people with Keratoconus, run by Oslo University Hospital at 1 site in Norway.
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 1 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: looking for participants now, as of the sponsor's last update on 16 Feb 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 Norway. 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?
Contact Olav Kristianslund, MD, PhD (+4722118545, olakri@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 month after surgery). The study lists 2 primary outcomes in all. 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 16 Feb 2024.