Treatment of Keratoconus With Advanced Corneal Crosslinking
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
The purpose of this study was to determine whether mechanical compression of the cornea during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve the optical outcomes of the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedDecember 11, 2020
December 1, 2020
5 years
April 13, 2015
December 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in refraction
Refractive errors, including lower and higher order aberrations in the cornea
1, 6, 24 and 60 months after the treatment
Secondary Outcomes (5)
Change from baseline in ETDRS LogMAR visual acuity
1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ORA
1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ART
1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with GAT
1, 6, 24 and 60 months after the treatment
Change from baseline in corneal densitometry
1, 6, 24 and 60 months after the treatment
Study Arms (4)
Corneal reshaping/crosslinking (CRXL)
EXPERIMENTALCorneal crosslinking with compression of the cornea using a sutured rigid contact lens during the treatment.
Corneal crosslinking (CXL)
ACTIVE COMPARATORStandard corneal crosslinking using the Dresden protocol.
Control group to CRXL
NO INTERVENTIONHealthy subjects, age- and sex-matched to the CRXL group.
Control group to CXL
NO INTERVENTIONHealthy subjects, age- and sex-matched to the CXL group.
Interventions
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
Eligibility Criteria
You may qualify if:
- Patients planned for corneal crosslinking.
- Progressive keratoconus documented with Scheimpflug photography using the Pentacam Scheimflug camera and/or repeated subjective refraction and keratometry.
- A keratoconus diagnosis based on the Amsler-Krumeich grading and the "Total Deviation" KC quantification value from the "Belin-Ambrosio enhanced ectasia" measurements of the Pentacam Scheimpflug camera, and an altered red reflex and/or an irregular cornea seen as distortion of the keratometric mires.
- Minimum corneal thickness of 400 µm at the thinnest point after epithelial removal.
- years of age
- No ocular abnormalities except keratoconus
- No previous ocular surgery
- No cognitive insufficiency interfering with the informed consent.
You may not qualify if:
- Age under 18 or over 28
- Any corneal abnormalities except keratoconus
- Previous ocular surgery
- Cognitive insufficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Related Publications (4)
Beckman Rehnman J, Behndig A, Hallberg P, Linden C. Initial results from mechanical compression of the cornea during crosslinking for keratoconus. Acta Ophthalmol. 2014 Nov;92(7):644-9. doi: 10.1111/aos.12380. Epub 2014 Mar 15.
PMID: 24628999BACKGROUNDBeckman Rehnman J, Behndig A, Hallberg P, Linden C. Increased corneal hysteresis after corneal collagen crosslinking: a study based on applanation resonance technology. JAMA Ophthalmol. 2014 Dec;132(12):1426-32. doi: 10.1001/jamaophthalmol.2014.3029.
PMID: 25171564BACKGROUNDBeckman Rehnman J, Janbaz CC, Behndig A, Linden C. Spatial distribution of corneal light scattering after corneal collagen crosslinking. J Cataract Refract Surg. 2011 Nov;37(11):1939-44. doi: 10.1016/j.jcrs.2011.05.028. Epub 2011 Aug 27.
PMID: 21873026RESULTRehnman JB, Linden C, Hallberg P, Behndig A. Treatment Effect and Corneal Light Scattering With 2 Corneal Cross-linking Protocols: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Nov;133(11):1254-60. doi: 10.1001/jamaophthalmol.2015.2852.
PMID: 26312777DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Behndig, Professor
Umeå University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 13, 2015
First Posted
April 23, 2015
Study Start
October 1, 2009
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 11, 2020
Record last verified: 2020-12