Corneal Crosslinking Treatment Study
Prospective Randomised Corneal Crosslinking Study
1 other identifier
interventional
54
1 country
1
Brief Summary
Three different protocols for inducing corneal crosslinks in subjets with progressive keratoconus will be evaluated in this randomised clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2017
CompletedFirst Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2024
CompletedNovember 22, 2024
July 1, 2024
7.5 years
June 3, 2020
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative change in visual acuity
Uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA)
Patients will be evaluated 1, 6, 12 and 24 months after treatment.
Postoperative change in Kmax
Maximum corneal steepness
Patients will be evaluated 1, 6, 12 and 24 months after treatment.
Secondary Outcomes (6)
Postoperative change in astigmatism
Patients will be evaluated 1, 6, 12 and 24 months after treatment.
postoperative change in corneal nerve cell density
Confocal microscopy will be performed at 6 and 12 months.
Postoperative change in Keratocyte cell density
Confocal microscopy will be performed at 6 and 12 months.
Postoperative change in endothelial cell count
Confocal microscopy will be performed at 6 and 12 months.
Postoperative change in demarcation lines
Confocal microscopy will be performed at 6 and 12 months.
- +1 more secondary outcomes
Study Arms (3)
Isotonic riboflavin
ACTIVE COMPARATORCXL (UVA 9mW/cm2) treatment using isotonic riboflavin
Hypotonic riboflavin
ACTIVE COMPARATORCXL (UVA 9mW/cm2) using hypotonic riboflavin
Iontophoresis
ACTIVE COMPARATORIontophoresis with Ricrolin with following CXL (UVA 9mW/cm2).
Interventions
CXL treatment with UVA-radiation (9mW/cm2) with a 10 minute irradiation protocol.
Eligibility Criteria
You may qualify if:
- Progress in keratoconic eye. We define progress as an increase in Kmax of 1.0 diopter in 1 year or 0.5 diopter in 6 months. This increase in Kmax will be accepted as progression if concomitant changes tomographic parameters.
You may not qualify if:
- Concurrent ocular infection or corneal disease other than keratoconus.
- Pregnancy.
- Treatment with Isotretinoin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Skåne University Hospital
Lund, Skåne County, 22242, Sweden
Related Publications (1)
Gustafsson I, Ivarsen A, Hjortdal J. Early findings in a prospective randomised study on three cross-linking treatment protocols: interruption of the iontophoresis treatment protocol. BMJ Open Ophthalmol. 2023 Sep;8(1):e001406. doi: 10.1136/bmjophth-2023-001406.
PMID: 37739426DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingemar Gustafsson, MD
Region Skåne
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 11, 2020
Study Start
May 23, 2017
Primary Completion
November 19, 2024
Study Completion
November 19, 2024
Last Updated
November 22, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share