Impact of Iridotomy/Iridectomy Size on Postoperative Pupillary Block and Dysphotopsia Following DMEK
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Descemet membrane endothelial keratoplasty (DMEK) represents the current standard procedure for surgical treatment of corneal endothelial diseases. During DMEK, a gas bubble is placed in the anterior chamber to attach the graft. In rare cases, this may lead to postoperative pupillary block with acute intraocular pressure elevation and severe pain. To prevent this complication, preoperative Nd:YAG laser iridotomy or intraoperative surgical iridectomy is routinely performed. Nevertheless, pupillary block continues to occur in a subset of patients.
One potential cause is an iridotomy or iridectomy that is too small or not fully patent, which may be misclassified as open on slit-lamp examination. Conversely, large iridotomy openings may induce postoperative dysphotopsia. Currently, no standardized recommendations exist regarding optimal IT size in the setting of DMEK, and systematic data correlating IT size with pupillary block and dysphotopsia are lacking.
This study is designed as a prospective, monocentric, non-interventional observational study. Adult patients undergoing DMEK at the Department of Ophthalmology, University Hospital Leipzig, with either preoperative laser iridotomy or intraoperative surgical iridectomy are invited to participate. AS-OCT imaging of the iris is performed preoperatively or postoperatively as an additional study-related diagnostic procedure to quantify IT size. All surgical procedures and clinical follow-up examinations remain unchanged from standard care.
Postoperatively, clinical outcomes including the occurrence of pupillary block are documented during routine follow-up. New postoperative dysphotopsia is assessed using a structured, German-adapted dysphotopsia questionnaire based on the instrument described by Vera et al., administered after resolution of the intracameral gas bubble and corneal edema.
The primary endpoint is the occurrence of postoperative pupillary block after DMEK. The secondary endpoint is the occurrence and severity of new postoperative dysphotopsia. A total of 100 consecutive patients will be included over a planned study period of 12 months. The study aims to explore associations between IT size and postoperative complications in order to improve perioperative risk stratification in DMEK surgery.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Christian Girbardt, Dr. med.
- Numéro de téléphone: +493419721650
- E-mail: christian.girbardt@medizin.uni-leipzig.de
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Occurrence of postoperative pupillary block after DMEK
Délai: Within the first five postoperative days, including day 0 (date of surgery)
|
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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Occurrence and severity of postoperative dysphotopsia
Délai: between 2 weeks and 1 year postoperatively
|
Assessed using a structured dysphotopsia questionnaire based on the instrument by Vera et al., providing an ordinal severity score.
|
between 2 weeks and 1 year postoperatively
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- DMEK-YAG
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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