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

NCT07577635 | Not Yet Recruiting

• 1 other identifier: DMEK-YAG
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pupillary Block After DMEK; Laser Iridotomy / Surgical Iridectomy; Dysphotopsia; Descemet Membrane Endothelial Keratoplasty (DMEK)

Outcome Measures

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.

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

Secondary Outcomes (1)

• Occurrence and severity of postoperative dysphotopsia

  between 2 weeks and 1 year postoperatively

Interventions

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Willingness to complete the postoperative dysphotopsia questionnaire

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leipzig: lead

Central Study Contacts

Christian Girbardt, Dr. med.

CONTACT

+493419721650; christian.girbardt@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Ophthalmology, University Hospital Leipzig

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: May 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share