Impact of Iridotomy/Iridectomy Size on Postoperative Pupillary Block and Dysphotopsia Following DMEK

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Leipzig

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Anterior Segment Optical Coherence Tomography (AS-OCT)

    Diagnostic test

    Additional 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 intervention

    Structured patient questionnaire to assess occurrence and severity of new postoperative dysphotopsia after DMEK.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Within the first five postoperative days, including day 0 (date of surgery)

Secondary outcomes

1

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.

Time frame
between 2 weeks and 1 year postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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