UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial

Table 2 Participant timeline of visits with procedures

Visits	Screening	Baseline	Control after CXL^a	Repeat study intervention^b	Control after the second CXL	Transplantation^c	FU
Trial points	Week −14 to −10	Week −10 to −8	Week −8 to −6	Week −6 to −4	Week −4 to −2	D 0	Week 12±2 wk	Week 24±2 wk	Week 48±2 wk	Week 72±2 wk	Week 96±2 wk
Eligibility and history	X
Informed consent	X
In-/exclusion criteria	X
Demographics	X
Medical history	X
Slit lamp exam	X	X	X		X		X	X	X	X	X
Standardized digital photo		X	X		X		X	X	X	X	X
Laser-FlareCell-Meter^d		X					X	X	X	X	X
Corneal tomography	X	X	X		X		X	X	X	X	X
SL-OCT	X	X	X		X		X	X	X	X	X
Visual acuity	X	X	X		X		X	X	X	X	X
Concomitant medication	X	X	X		X		X	X	X	X	X
Randomization^e	X
Vision-related quality of life		X					X	X	X	X	X
CXL (intervention group only)		X		X
Transplantation						X
AE review and evaluation			X	X	X		X	X	X	X	X
Corneal endothelial count							X	X	X	X	X
Macula OCT^f	X						X	X	X	X	X

AE Adverse event, CXL Corneal crosslinking, FU Follow-up, EOT End of trial, SL-OCT Slit lamp optical coherence tomography
^aTwo weeks after the first CXL, ^bwhen regression of corneal neovascularization is < 50%, repeat CXL 4 weeks after first CXL, ^cdepending on availability of the graft and randomization, transplantation will take place between 8 and 10 weeks after baseline visit, ^doptional (if available), ^eafter obtaining IC and completion of screening, ^fif deemed necessary by the investigator

ISSN: 1745-6215