Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870566
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-05-03
Brief Title:
Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation CrossCornealVision
Sponsor:
Claus Cursiefen
Organization:
University of Cologne
Study Overview
Official Title:
UV Light-mediated Corneal Crosslinking as LymphAngioregressive Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation CrossCornealVision
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial evaluates the effect of corneal crosslinking as pre-treatment before corneal transplantation The goal is to improve graft survival by reducing pathological vessels through pre-treatment
Detailed Description:
Multicenter two armed controlled open randomised parallel-group study to evaluate the effect of corneal crosslinking as pre-treatment vs no pre-treatment ahead of full-thickness penetrating corneal transplantation
After screening of inclusion and exclusion criteria eligible subjects will be included after obtaining informed consent Randomisation will be performed at a 54 ratio Protocol V04_0 Page 37 At the baseline assessment a slit lamp examination and photo documentation as well as LaserFlareCellMeter if available corneal tomography and Slit lamp Adapted Optical Coherence Tomography SL-OCT measurements will be performed In addition visual acuity and a vision-related quality of life will be assessed Concomitant medication will be documented Macula OCT will be performed if deemed necessary In the intervention arm the study intervention CXL will then be administered to reduce CoNV 10-8 weeks prior to corneal transplantation Two weeks after CXL a control will be performed including AE documentation slit lamp examination SL-OCT corneal tomography visual acuity and photo documentation The study intervention will be repeated once if insufficient less than 50 reduction of CoNV should be observed 4 weeks prior to corneal transplantation at the latest All subjects in the intervention arm will then undergo for corneal transplantation In the control arm subjects will be directly scheduled for corneal transplantation Corneal transplantation will be performed as standard full-thickness penetrating procedure and the graft 65 - 825 mm 775 mm in diameter will be secured with 16-24 interrupted single or double running 10-0 nylon single sutures decision by the surgeon Postoperatively follow-up assessments will be performed at 3 6 12 18 and 24 months for all subjects postoperative visits at these time points are standard of care A slit lamp examination concomitant medication AE and photo documentation as well as LaserFlareCellMeter if available corneal tomography SL-OCT and corneal endothelial cell count measurements will be performed In addition visual acuity and a vision-related quality of life will be assessed Macula OCT will be performed if deemed necessary If a subject has any complaints he or she can contact the responsible trial site at any time
After consultation with the investigator additional visits can be scheduled Protocol V04_0 Page 50
After screening of inclusion and exclusion criteria eligible subjects will be included after obtaining informed consent Randomisation will be performed at a 54 ratio Protocol V04_0 Page 37 At the baseline assessment a slit lamp examination and photo documentation as well as LaserFlareCellMeter if available corneal tomography and Slit lamp Adapted Optical Coherence Tomography SL-OCT measurements will be performed In addition visual acuity and a vision-related quality of life will be assessed Concomitant medication will be documented Macula OCT will be performed if deemed necessary In the intervention arm the study intervention CXL will then be administered to reduce CoNV 10-8 weeks prior to corneal transplantation Two weeks after CXL a control will be performed including AE documentation slit lamp examination SL-OCT corneal tomography visual acuity and photo documentation The study intervention will be repeated once if insufficient less than 50 reduction of CoNV should be observed 4 weeks prior to corneal transplantation at the latest All subjects in the intervention arm will then undergo for corneal transplantation In the control arm subjects will be directly scheduled for corneal transplantation Corneal transplantation will be performed as standard full-thickness penetrating procedure and the graft 65 - 825 mm 775 mm in diameter will be secured with 16-24 interrupted single or double running 10-0 nylon single sutures decision by the surgeon Postoperatively follow-up assessments will be performed at 3 6 12 18 and 24 months for all subjects postoperative visits at these time points are standard of care A slit lamp examination concomitant medication AE and photo documentation as well as LaserFlareCellMeter if available corneal tomography SL-OCT and corneal endothelial cell count measurements will be performed In addition visual acuity and a vision-related quality of life will be assessed Macula OCT will be performed if deemed necessary If a subject has any complaints he or she can contact the responsible trial site at any time
After consultation with the investigator additional visits can be scheduled Protocol V04_0 Page 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01KG2127 | OTHER_GRANT | German Federal Ministry of Education and Research BMBF | None |