About this trial
Descemet membrane endothelial keratoplasty (DMEK) is the standard surgical treatment for corneal endothelial disorders. A postoperative pupillary block may occur despite routine preoperative laser iridotomy or intraoperative surgical iridectomy. Insufficient size or incomplete patency of the iridotomy/iridectomy (IT) may contribute to this complication, while excessively large openings may be associated with postoperative dysphotopsia. This prospective observational study investigates the association between IT size measured by anterior segment optical coherence tomography (AS-OCT) and the occurrence of postoperative pupillary block and dysphotopsia after DMEK.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥ 18 years
Patients undergoing Descemet membrane endothelial keratoplasty (DMEK) at the Department of Ophthalmology, University Hospital Leipzig
Preoperative Nd:YAG laser iridotomy or intraoperative surgical iridectomy performed as part of standard care
Ability to provide written informed consent
Disqualifiers
Inability to provide informed consent or refusal to participate
Pre-existing surgical iridectomy
Missing or incomplete preoperative or postoperative anterior segment OCT data
Active anterior uveitis or panuveitis at the time of surgery
Trial population
Adult patients undergoing Descemet membrane endothelial keratoplasty (DMEK) for corneal endothelial disease at the Department of Ophthalmology, University Hospital Leipzig, in whom a preoperative laser iridotomy or intraoperative surgical iridectomy is performed as part of standard care.
Trial design
Cohort
Prospective
Treatments tested in this trial
Anterior Segment Optical Coherence Tomography (AS-OCT)
Diagnostic testAdditional anterior segment OCT imaging of the iris to quantify the size and patency of the iridotomy or iridectomy in DMEK patients, performed as a non-invasive, contact-free study-related diagnostic procedure alongside routine clinical examinations.
Dysphotopsia Questionnaire
Other interventionStructured patient questionnaire to assess occurrence and severity of new postoperative dysphotopsia after DMEK.
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of postoperative pupillary block after DMEK
Pupillary block is defined as intraocular pressure \>25 mmHg with a centrally deep anterior chamber and partial or complete peripheral angle closure.
Secondary outcomes
Occurrence and severity of postoperative dysphotopsia
Assessed using a structured dysphotopsia questionnaire based on the instrument by Vera et al., providing an ordinal severity score.
Locations
Sponsors and contacts
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