KeratoconusC-CROSSNCT04532788
Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking
A study testing Customized crosslinking and Standard crosslinking in people with Keratoconus, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
The standard or Dresden protocol was established in 2003 and treats the entire cornea. However, recent ultra-structural research showed that keratoconus is localized. Therefore, treating only the affected zone and minimalizing the risk of damaging surrounding tissues would be beneficial. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Customized crosslinking and Standard crosslinking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Mar 2021to 5 Jun 2024
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Progressive keratoconus based on an increase of maximum keratometry (Kmax) of 1 diopter (D) over a time period of 12 months
Who cannot join
- Corneal scarring
- Corneal disease other than keratoconus
- History of corneal surgery (e.g. refractive surgery, corneal transplantation, intracorneal ring segments)
- Patient unwilling or unable to give informed consent, unwilling to accept randomization or inability to complete follow-up (e.g. hospital visits) or comply with study procedures
- Insufficient corneal thickness including epithelium < 375 µm
- Pregnancy
- Among patients in whom both eyes are eligible only the first eye which is undergoing corneal cross-linking is enrolled in the study
- Participation in another clinical study
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
University Medical Center Groningen
Groningen, 9713 GZ
Maastricht University Medical Center (MUMC+)
Maastricht, Limburg, 6229 HX
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: Efficacy of Customized Corneal Cross-linking Versus Standard Corneal Cross-linking in Patients With Progressive Keratoconus
The standard or Dresden protocol was established in 2003 and treats the entire cornea. However, recent ultra-structural research showed that keratoconus is localized. Therefore, treating only the affected zone and minimalizing the risk of damaging surrounding tissues would be beneficial.
The objective of this study is to evaluate whether the effectiveness of customized cross-linking (cCXL) is non-inferior to standard accelerated cross-linking (sCXL) in terms of flattening of the cornea and halting keratoconus progression.
Read the detailed description
In 2003 Wollensak et al used corneal cross-linking (CXL) in humans to halt the progression of keratoconus. During the procedure the top layer of the cornea, the epithelium, is debrided. Then the cornea is soaked with riboflavin, a photosensitizer. Hereafter a 9.0 mm diameter Ultraviolet-A (UVA) beam radiates the cornea for 30 minutes with a fluence of 3 mW/cm2 resulting in a total energy of 5,4 J/cm2. This protocol is called the Dresden protocol. Currently, accelerated versions of the Dresden protocol are used in common practice. There are different accelerated protocols with fluences of 9mW/cm2, 10mW/cm2 and 15 mW/cm2. The higher the fluence, the shorter the treatment time, however according to the Bunsen-Roscoe reciprocity law the total amount of energy stays the same.During the procedure oxygen radicals are formed that interact with the surrounding molecules, leading to the formation of new chemical bounds between the collagen fibrils (i.e. corneal crosslinks). The final goal of the procedure is to cause the cornea to stiffen and achieve flattening of the treated region.
For any treatment, it is imperative that the unaffected region of the tissue is not unnecessarily treated by an intervention or drug application. To minimalize the risk of damage to surrounding tissues it would be beneficial that the UVA beam is restricted to the affected, keratoconic zone in the patient's cornea. This can be achieved by customizing the beam shape and size in a way that only the degenerated zone is treated, i.e. by customized cross-linking (cCXL). Recently published studies provide clinical evidence that similar clinical outcomes (amount of corneal flattening) can be achieved when only the cone is treated instead of the entire cornea.They also show the potential benefits of cCXL, e.g. the treatment is patient-specific, a smaller surface of the cornea is irradiated, lower incidence of corneal haze, a faster reepithelialisation and a shorter procedure time. However, none of these studies are randomized and study results are limited by using small sample sizes. Therefore, we feel that there is a great need for a randomized controlled trial with an appropriate design and sample size to confirm these findings.
The aim of this study is to investigate if cCXL is non-inferior to sCXL (10 mW/cm2) in terms of flattening of the corneal surface and halting the disease progression.
- Conditions
- Keratoconus
- Being tested
- Customized crosslinking, Standard crosslinking
- Keywords
- Keratoconus, Crosslinking, Customized
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized crosslinkingProcedure or surgery
In the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size.
The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).
Standard crosslinkingProcedure or surgery
In the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2.
The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).
| Study group | Role | What they receive |
|---|---|---|
| Customized crosslinking | Active comparator | In the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size.
The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States). Receives: Procedure: Customized crosslinking |
| Standard crosslinking | Active comparator | In the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2.
The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States). Receives: Procedure: Standard crosslinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum keratometry (Kmax)
Kmax is measured with Scheimpflug photography (Pentacam® HR, OCULUS Optikgeraete GmbH, Wetzlar, Germany)
Measured: 12 months postoperatively
Secondary outcomes (22)
Visual acuity
Measured with ETDRS
Measured: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
Refraction
Change in spherical equivalent
Measured: at baseline and 12 months postoperatively
Depth and size of demarcation line
Measured with AS OCT
Measured: at 4 weeks and 12 months postoperatively
Pachymetry
Measured with the Pentacam HR
Measured: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
Zonal Kmax
The analysis of a 3.0 mm zone centered on Kmax measured with the Pentacam HR
Measured: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
DUCK score
Dutch Crosslinking for Keratconus Score is based on changes in 5 clinical parameters that are routinely assessed: age, visual acuity, refraction error, keratometry, and subjective patient experience. Each items is scored from 0 to 2 and cutoffs are determined by clinical experience.
Measured: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
ABCD grading system
Anterior radius of curvature (A), Posterior radius of curvature (B), Corneal pachymetry at thinnest point (C), Distance best corrected vision (D), and a modifier (-) for no scarring, (+) for scarring that does not obscure iris details and (++) for scarring that obscures iris details
Measured: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
Success/failure rate
Failure is defined as progression of the disease after CXL. Progression is defined as an increase in Kmax >1D over 12 months, an increase in K1 and/or K2 >1D over 12 months and thinning and/or an increase in the rate of corneal thickness change from the periphery to the thinnest point >10% over 12 months
Measured: at 12 months postoperatively
Mean endothelial cell loss
Measured using specular microscopy photography
Measured: at 6 and 12 months postoperatively
Rate of reepithelialisation
evaluated with fluorescein and blue light, a slit lamp image is taking to perform quantitative morphometric surface analysis
Measured: 4 days postoperatively
Patient Reported Outcomes Measures (PROMs)
Health-related quality of life as measured by HUI3 (Health Utility Index Mark 3) questionnaire
Measured: at baseline, 3 months, 6 months and 12 months postoperatively
Patient Reported Outcomes Measures (PROM)
Patient satisfaction and vision-specific quality of life as measured by National Eye Institute Visual Function Questionnaire (NEI VFQ-25)
Measured: at baseline, 3 months, 6 months and 12 months postoperatively
Patient Reported Outcomes Measures (PROM)
Patient satisfaction and vision-specific quality of life as measured by Keratoconus Outcome Research Questionnaire (KORQ)
Measured: at baseline, 3 months, 6 months and 12 months postoperatively
Pain after crosslinking
measured with the short form of the McGill Pain Questionnaire (SF-MPQ)
Measured: 4 days postoperatively
Quality Adjusted Life Years (QALYs)
Calculated based on generic health-related quality of life, using the EQ-5D-5L questionnaire
Measured: baseline until 12 months postoperatively
Quality Adjusted Life Years (QALYs)
Calculated based on generic health-related quality of life, using the HUI-3 questionnaire
Measured: baseline until 12 months postoperatively
Costs per patient
Cost per patient, including valuation of resource use by using the Dutch guidelines for cost-analyses or cost prices provided by the medical center.
Measured: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY
Evaluation of cost-effectiveness by using calculated costs per quality-adjusted life years (QALYs)
Measured: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Calculated costs per clinically improved patient on the NEI VFQ-25 questionnaire
Measured: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Kmax
incremental healthcare costs per patient with a reduction in Kmax of ≥ 1D after crosslinking
Measured: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): visual acuity
incremental healthcare costs per patient with clinical improvement in (un-) corrected distance visual acuity
Measured: baseline until 12 months postoperatively
Budget impact
Reported as a difference in costs. Different scenario's will be compared to investigate the impact of various levels of implementation (e.g. 25%, 50%, 75% of eligible patients)
Measured: baseline until 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Mar 2021
- Primary completion1 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- R.M.M.A. Nuijts, MD, PhD, Principal investigator, Department of Ophthalmology, Maastricht University Medical Center (MUMC+)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532788
- Sponsor's protocol ID
- NL73003.068.20
- Acronym
- C-CROSS
- Status last verified
- Mar 2023
- First submitted
- 20 Aug 2020
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vandevenne MMS, Berendschot TTJM, Winkens B, van den Biggelaar FJHM, Visser N, Dickman MM, Wisse RPL, Wijdh RHJ, Roy AS, Shetty R, Nuijts RMMA. Efficacy of customized corneal crosslinking versus standard corneal crosslinking in patients with progressive keratoconus (C-CROSS study): study protocol for a randomized controlled trial. BMC Ophthalmol. 2023 May 19;23(1):224. doi: 10.1186/s12886-023-02976-4.
PubMed 37208674
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Customized Corneal Cross-linking Versus Standard Corneal Cross-linking in Patients With Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT04532788
- Acronym / sponsor ID
- C-CROSS / NL73003.068.20
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Crosslinking, Customized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 31 Aug 2020 (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 standard or Dresden protocol was established in 2003 and treats the entire cornea. However, recent ultra-structural research showed that keratoconus is localized. Therefore, treating only the affected zone and minimalizing the risk of damaging surrounding tissues would be beneficial.
The objective of this study is to evaluate whether the effectiveness of customized cross-linking (cCXL) is non-inferior to standard accelerated cross-linking (sCXL) in terms of flattening of the cornea and halting keratoconus progression.
Detailed description
In 2003 Wollensak et al used corneal cross-linking (CXL) in humans to halt the progression of keratoconus. During the procedure the top layer of the cornea, the epithelium, is debrided. Then the cornea is soaked with riboflavin, a photosensitizer. Hereafter a 9.0 mm diameter Ultraviolet-A (UVA) beam radiates the cornea for 30 minutes with a fluence of 3 mW/cm2 resulting in a total energy of 5,4 J/cm2. This protocol is called the Dresden protocol. Currently, accelerated versions of the Dresden protocol are used in common practice. There are different accelerated protocols with fluences of 9mW/cm2, 10mW/cm2 and 15 mW/cm2. The higher the fluence, the shorter the treatment time, however according to the Bunsen-Roscoe reciprocity law the total amount of energy stays the same.During the procedure oxygen radicals are formed that interact with the surrounding molecules, leading to the formation of new chemical bounds between the collagen fibrils (i.e. corneal crosslinks). The final goal of the procedure is to cause the cornea to stiffen and achieve flattening of the treated region.
For any treatment, it is imperative that the unaffected region of the tissue is not unnecessarily treated by an intervention or drug application. To minimalize the risk of damage to surrounding tissues it would be beneficial that the UVA beam is restricted to the affected, keratoconic zone in the patient's cornea. This can be achieved by customizing the beam shape and size in a way that only the degenerated zone is treated, i.e. by customized cross-linking (cCXL). Recently published studies provide clinical evidence that similar clinical outcomes (amount of corneal flattening) can be achieved when only the cone is treated instead of the entire cornea.They also show the potential benefits of cCXL, e.g. the treatment is patient-specific, a smaller surface of the cornea is irradiated, lower incidence of corneal haze, a faster reepithelialisation and a shorter procedure time. However, none of these studies are randomized and study results are limited by using small sample sizes. Therefore, we feel that there is a great need for a randomized controlled trial with an appropriate design and sample size to confirm these findings.
The aim of this study is to investigate if cCXL is non-inferior to sCXL (10 mW/cm2) in terms of flattening of the corneal surface and halting the disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized crosslinking | Active comparator | Procedure: Customized crosslinkingIn the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size. The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States). |
| Standard crosslinking | Active comparator | Procedure: Standard crosslinkingIn the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2. The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States). |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Progressive keratoconus based on an increase of maximum keratometry (Kmax) of 1 diopter (D) over a time period of 12 months
Key exclusion criteria (8 listed)
- Corneal scarring
- Corneal disease other than keratoconus
- History of corneal surgery (e.g. refractive surgery, corneal transplantation, intracorneal ring segments)
- Patient unwilling or unable to give informed consent, unwilling to accept randomization or inability to complete follow-up (e.g. hospital visits) or comply with study procedures
- Insufficient corneal thickness including epithelium < 375 µm
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 |
|---|---|---|
| Customized crosslinkingIn the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size. The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States). | Procedure or surgery | Customized crosslinking |
| Standard crosslinkingIn the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2. The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States). | Procedure or surgery | Standard crosslinking |
Primary outcome
Change in maximum keratometry (Kmax)
Time frame: 12 months postoperatively
Kmax is measured with Scheimpflug photography (Pentacam® HR, OCULUS Optikgeraete GmbH, Wetzlar, Germany)
22 secondary outcomes
Visual acuity
Time frame: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
Refraction
Time frame: at baseline and 12 months postoperatively
Depth and size of demarcation line
Time frame: at 4 weeks and 12 months postoperatively
Pachymetry
Time frame: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
Zonal Kmax
Time frame: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
DUCK score
Time frame: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
ABCD grading system
Time frame: at baseline, 4 weeks, 3 months, 6 months and 12 months postoperatively
Success/failure rate
Time frame: at 12 months postoperatively
Mean endothelial cell loss
Time frame: at 6 and 12 months postoperatively
Rate of reepithelialisation
Time frame: 4 days postoperatively
Patient Reported Outcomes Measures (PROMs)
Time frame: at baseline, 3 months, 6 months and 12 months postoperatively
Patient Reported Outcomes Measures (PROM)
Time frame: at baseline, 3 months, 6 months and 12 months postoperatively
Patient Reported Outcomes Measures (PROM)
Time frame: at baseline, 3 months, 6 months and 12 months postoperatively
Pain after crosslinking
Time frame: 4 days postoperatively
Quality Adjusted Life Years (QALYs)
Time frame: baseline until 12 months postoperatively
Quality Adjusted Life Years (QALYs)
Time frame: baseline until 12 months postoperatively
Costs per patient
Time frame: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): QALY
Time frame: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): NEI VFQ-25
Time frame: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): Kmax
Time frame: baseline until 12 months postoperatively
Incremental cost-effectiveness ratios (ICERs): visual acuity
Time frame: baseline until 12 months postoperatively
Budget impact
Time frame: baseline until 12 months postoperatively
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 Jun 2024.
- Derived from this study: PubMed 37208674Vandevenne MMS, Berendschot TTJM, Winkens B, van den Biggelaar FJHM, Visser N, Dickman MM, Wisse RPL, Wijdh RHJ, Roy AS, Shetty R, Nuijts RMMA. Efficacy of customized corneal crosslinking versus standard corneal crosslinking in patients with progressive keratoconus (C-CROSS study): study protocol for a randomized controlled trial. BMC Ophthalmol. 2023 May 19;23(1):224. doi: 10.1186/s12886-023-02976-4.
- 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. This study is not recruiting at the moment.
R.M.M.A. Nuijts, MD, PhD principal investigator
Department of Ophthalmology, Maastricht University Medical Center (MUMC+)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized crosslinking and Standard crosslinking in people with Keratoconus, run by Maastricht University Medical Center at 3 sites in Netherlands.
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 1 inclusion and 8 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
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 in maximum keratometry (Kmax) (time frame: 12 months postoperatively). 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 NCT04532788, which also lists 1 linked publication.
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 Jun 2024.