Refractive Corneal Cross-linking for Progressive Keratoconus
NCT ID: NCT03531047
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2018-11-01
2019-11-27
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Refractive CXL
Tomography-customised CXL
Customised CXL
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.
Interventions
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Customised CXL
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Corrected distance visual acuity (CDVA) \< 0.00 logMAR
Exclusion Criteria
* Active ocular surface disease
* Minimum corneal thickness \< 375 µm
* Vulnerable groups
* Pregnancy
18 Years
ALL
No
Sponsors
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Moorfields Eye Hospital NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Daniel M Gore
Role: PRINCIPAL_INVESTIGATOR
Moorfields Eye Hospital NHS Foundation Trust
Locations
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Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
O'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.
Other Identifiers
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GORD1003
Identifier Type: -
Identifier Source: org_study_id