Antisense Oligonucleotide Eye Drops against IRS-1 to Optimize Pretransplant Lymphangio-regression Prior to High-Risk Keratoplasty (Olisens-Precon)

Condition studied

Pathologically prevascularized corneas due to herpetic keratopathy prior to “high-risk” corneal transplantation (keratoplasty)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Relative change in the corneal area covered by CoNV measured by digital standardized slit-lamp images.

Endpoint detail

Best corrected visual acuity measured by ETDRS charts (transformed to LogMAR (Logarithm of the Minimum Angle of Resolution)), Best corrected glare visual acuity measured by ETDRS charts (transformed to LogMAR (Loga-rithm of the Minimum Angle of Resolution)), Vision related Quality of Life assessed by overall score of NEI-VFQ25, Intraocular Pressure measured by Goldmann applanation tonometry, reported as mmHg, Ocular Surface Staining according to Oxford Grading Scale (Grades 0-5), Corneal Sensation measured by length of the nylon monofilament of Cochet-Bonnet esthesiometer when the applied pressure is noticed by the participants, Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2), Vessel Morphometry (vessel thickness, vessel length, vessel regression, vessel recurrence), Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Assessment Survey (OPAS), Safety: Retinal adverse events (Optical Coherence Tomography), Change in need for subsequent transplantation (as assessed by PI), Compliance of CXL postoperative medication recorded via daily patient self-documentation