Corneal disease/opacification treated with corneal endothelial transplantation (DSAEK or DMEK surgery), and the medical treatment is anti-inflammatory eye drops to treat (and prevent) intraocular inflammation and development of cystoid macular edema.
Conditions
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study if all of the following criteria apply: • Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit. • Scheduled for DSAEK or DMEK • Ability to cooperate fairly well during the examinations • Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: • Contraindications for use of any medication (e.g. allergy, pregnancy, breastfeeding) o Pregnancy or possible pregnancy during the study period is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5 • Preoperative macular edema and/or ongoing treatment for macular edema • Re-transplantation • In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve) • Aphakic eyes • Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen) For patients scheduled for corneal endothelial keratoplasty in both eyes, only the first operated eye will be included, however, both eyes will be examined.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare postoperative intraocular inflammation and affection of the macula between two different medication regimens after corneal endothelial transplantation (DSAEK or DMEK surgery);Secondary Objective: •Compare central macular thickness and the risk of cystoid macular edema •Compare visual outcome •Compare intraocular pressure •Compare corneal endothelial cell density •Compare patient-reported outcome measures ---between the medication groups;Primary end point(s): •Central macular thickness and macular cysts on optical coherence tomography ;Timepoint(s) of evaluation of this end point: Preoperatively, 1 week, 4 weeks, 2 months, 2 years after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • • Laser flare • Peroperative factors (e.g. operation time (minutes), iris lesion (none, some, much), pigment loss (none, some, much), intraocular manipulation ((none, some, much)) • IOP in mmHg (applanation and iCare) • Corrected distance visual acuity (in logMAR) • Corneal endothelial cell density (measured with confocal microscopy, in cells/mm2) • COMTol questionnaire for ocular medication ;Timepoint(s) of evaluation of this end point: Preoperatively, peroperatively, 1 day, 1 week, 4 weeks, 2 months, 2 years after surgery | — |
Countries
Norway
Contacts
Public ContactSection for Anterior Eye Segment
Oslo University Hospital
Outcome results
None listed