KeratoconusNCT03531047
Refractive Corneal Cross-linking for Progressive Keratoconus
A study testing Customised CXL in people with Keratoconus, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Young patients with keratoconus face two problems: disease progression and corneal shape irregularity. Both underlie the 20% rate of corneal transplantation in keratoconics required to maintain useful vision. Corneal collagen cross-linking (CXL) is a now the gold-standard treatment to halt disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Customised CXL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 27 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with progressive stage I - III keratoconus
- Corrected distance visual acuity (CDVA) < 0.00 logMAR
Who cannot join
- Patients under the age of 18 years
- Active ocular surface disease
- Minimum corneal thickness < 375 µm
- Vulnerable groups
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
About this study
Official title: A Prospective, Controlled Study of Refractive Corneal Cross-linking for Progressive Keratoconus
Young patients with keratoconus face two problems: disease progression and corneal shape irregularity. Both underlie the 20% rate of corneal transplantation in keratoconics required to maintain useful vision.
Corneal collagen cross-linking (CXL) is a now the gold-standard treatment to halt disease progression. The aim is to strengthen the cornea to prevent further shape deterioration. For patients whose quality of vision has already suffered, standard CXL can generally only prevent further deterioration, rather than improving vision. Refractive CXL, a new iteration of CXL in which a bespoke treatment pattern is applied to the cornea, aims to smooth out surface irregularities thereby improving vision.
This primary objective of this study is to compare the visual outcome in patients with progressive keratoconus treated with refractive CXL, as compared with historical controls treated with standard CXL.
Read the detailed description
Irregular astigmatism (irregular corneal shape leading to irregular focus) is a common cause of failure to achieve an adequate spectacle correction for many patients with corneal disease. For patients affected, rigid gas permeable contact lenses are the only means of visual rehabilitation. Not all patients tolerate rigid contact lens wear, and those that do are often uncomfortable and have a restricted wearing time.
Keratoconus, in which the corneal shape becomes progressively steeper and more irregular in the 2nd to 4th decades of life, is a common cause of irregular astigmatism. Disease progression in keratoconus can be stabilised with corneal collagen cross-linking (CXL), effective in 90% of cases. Pre-existing irregular astigmatism often remains after CXL, with many patients requiring rigid gas permeable contact lenses to regain good vision.
The investigators have recently demonstrated improvements in vision following simultaneous combined cross-linking with laser refractive surgery (TransPRK/CXL). The excimer laser is used to create a smoother, more regular focusing shape on the cornea to improve the quality of vision achieved in spectacles. Although effective, the downsides of using this approach are both the cost and limited availability of excimer laser equipment in the National Health Service (NHS) in the United Kingdom. Also, excimer laser smoothing works by removing corneal tissue. It is not yet known whether this tissue removal will have any detrimental effect on corneal shape stability post CXL.
As a cheaper and potentially more widely accessible alternative, refractive CXL aims to regularise the corneal surface by applying a bespoke treatment pattern based on pre-operative corneal surface shape (topography) scans. At least two-thirds of patients undergoing standard CXL already have impaired vision at the time treatment. The investigators are aiming to offer these patients both long-term stability of their keratoconus and an improvement in vision in a single treatment.
- Conditions
- Keratoconus
- Being tested
- Customised CXL
- Keywords
- progressive, cross-linking, customised, refractive
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customised CXLProcedure or surgery
Also called Riboflavin drops (drug): Vibex Rapid (Avedro Inc.)
As for standard CXL, following mechanical removal of the corneal surface layer (epithelium), 0.1% riboflavin drops will be applied every 2 minutes for 10 minutes prior to ultraviolet A (UVA) irradiation - UVA power, distribution and timing as determined by analysis of Pentacam tomography scans. A bandage contact lens will be applied to encourage regrowth of the corneal surface and reduce post-operative pain.
| Study group | Role | What they receive |
|---|---|---|
| Refractive CXL | Experimental | Tomography-customised CXL Receives: Procedure: Customised CXL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corrected distance visual acuity
LogMAR corrected vision in spectacles
Measured: 24 months
Secondary outcomes (4)
Change in uncorrected distance visual acuity
LogMAR uncorrected vision without spectacles
Measured: 24 months
Manifest refraction
Spectacle prescription
Measured: 24 months
Tomography
Corneal Pentacam indices
Measured: 24 months
Rates of keratitis
Complications of CXL
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Nov 2018
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel M Gore, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531047
- Sponsor's protocol ID
- GORD1003
- Status last verified
- Dec 2023
- First submitted
- 8 May 2018
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gore DM, Shortt AJ, Allan BD. New clinical pathways for keratoconus. Eye (Lond). 2013 Mar;27(3):329-39. doi: 10.1038/eye.2012.257. Epub 2012 Dec 21.
PubMed 23258309O'Brart DP, Chan E, Samaras K, Patel P, Shah SP. A randomised, prospective study to investigate the efficacy of riboflavin/ultraviolet A (370 nm) corneal collagen cross-linkage to halt the progression of keratoconus. Br J Ophthalmol. 2011 Nov;95(11):1519-24. doi: 10.1136/bjo.2010.196493. Epub 2011 Feb 24.
PubMed 21349938
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled Study of Refractive Corneal Cross-linking for Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT03531047
- Acronym / sponsor ID
- GORD1003
- Conditions
- Keratoconus
- Keywords
- progressive, cross-linking, customised, refractive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 21 May 2018 (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.
Young patients with keratoconus face two problems: disease progression and corneal shape irregularity. Both underlie the 20% rate of corneal transplantation in keratoconics required to maintain useful vision.
Corneal collagen cross-linking (CXL) is a now the gold-standard treatment to halt disease progression. The aim is to strengthen the cornea to prevent further shape deterioration. For patients whose quality of vision has already suffered, standard CXL can generally only prevent further deterioration, rather than improving vision. Refractive CXL, a new iteration of CXL in which a bespoke treatment pattern is applied to the cornea, aims to smooth out surface irregularities thereby improving vision.
This primary objective of this study is to compare the visual outcome in patients with progressive keratoconus treated with refractive CXL, as compared with historical controls treated with standard CXL.
Detailed description
Irregular astigmatism (irregular corneal shape leading to irregular focus) is a common cause of failure to achieve an adequate spectacle correction for many patients with corneal disease. For patients affected, rigid gas permeable contact lenses are the only means of visual rehabilitation. Not all patients tolerate rigid contact lens wear, and those that do are often uncomfortable and have a restricted wearing time.
Keratoconus, in which the corneal shape becomes progressively steeper and more irregular in the 2nd to 4th decades of life, is a common cause of irregular astigmatism. Disease progression in keratoconus can be stabilised with corneal collagen cross-linking (CXL), effective in 90% of cases. Pre-existing irregular astigmatism often remains after CXL, with many patients requiring rigid gas permeable contact lenses to regain good vision.
The investigators have recently demonstrated improvements in vision following simultaneous combined cross-linking with laser refractive surgery (TransPRK/CXL). The excimer laser is used to create a smoother, more regular focusing shape on the cornea to improve the quality of vision achieved in spectacles. Although effective, the downsides of using this approach are both the cost and limited availability of excimer laser equipment in the National Health Service (NHS) in the United Kingdom. Also, excimer laser smoothing works by removing corneal tissue. It is not yet known whether this tissue removal will have any detrimental effect on corneal shape stability post CXL.
As a cheaper and potentially more widely accessible alternative, refractive CXL aims to regularise the corneal surface by applying a bespoke treatment pattern based on pre-operative corneal surface shape (topography) scans. At least two-thirds of patients undergoing standard CXL already have impaired vision at the time treatment. The investigators are aiming to offer these patients both long-term stability of their keratoconus and an improvement in vision in a single treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractive CXL | Experimental | Procedure: Customised CXLTomography-customised CXL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with progressive stage I - III keratoconus
- Corrected distance visual acuity (CDVA) < 0.00 logMAR
Key exclusion criteria (5 listed)
- Patients under the age of 18 years
- Active ocular surface disease
- Minimum corneal thickness < 375 µm
- Vulnerable groups
- Pregnancy
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 |
|---|---|---|
| Customised CXLAlso: Riboflavin drops (drug): Vibex Rapid (Avedro Inc.)As for standard CXL, following mechanical removal of the corneal surface layer (epithelium), 0.1% riboflavin drops will be applied every 2 minutes for 10 minutes prior to ultraviolet A (UVA) irradiation - UVA power, distribution and timing as determined by analysis of Pentacam tomography scans. A bandage contact lens will be applied to encourage regrowth of the corneal surface and reduce post-operative pain. | Procedure or surgery | Refractive CXL |
Primary outcome
Change in corrected distance visual acuity
Time frame: 24 months
LogMAR corrected vision in spectacles
4 secondary outcomes
Change in uncorrected distance visual acuity
Time frame: 24 months
Manifest refraction
Time frame: 24 months
Tomography
Time frame: 24 months
Rates of keratitis
Time frame: 24 months
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 8 Dec 2023.
- Results publication: PubMed 23258309Gore DM, Shortt AJ, Allan BD. New clinical pathways for keratoconus. Eye (Lond). 2013 Mar;27(3):329-39. doi: 10.1038/eye.2012.257. Epub 2012 Dec 21.
- Results publication: PubMed 21349938O'Brart DP, Chan E, Samaras K, Patel P, Shah SP. A randomised, prospective study to investigate the efficacy of riboflavin/ultraviolet A (370 nm) corneal collagen cross-linkage to halt the progression of keratoconus. Br J Ophthalmol. 2011 Nov;95(11):1519-24. doi: 10.1136/bjo.2010.196493. Epub 2011 Feb 24.
- Individual participant dataSharing planned: No
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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.
Daniel M Gore principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customised CXL in people with Keratoconus, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 5 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 8 Dec 2023. 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 United Kingdom. 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 corrected distance visual acuity (time frame: 24 months). 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 NCT03531047, which also lists 2 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 8 Dec 2023.