Impact of Iridotomy/Iridectomy Size on Postoperative Pupillary Block and Dysphotopsia Following DMEK
Descripción general del estudio
Estado
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Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Christian Girbardt, Dr. med.
- Número de teléfono: +493419721650
- Correo electrónico: christian.girbardt@medizin.uni-leipzig.de
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- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
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Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of postoperative pupillary block after DMEK
Periodo de tiempo: Within the first five postoperative days, including day 0 (date of surgery)
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Pupillary block is defined as intraocular pressure >25 mmHg with a centrally deep anterior chamber and partial or complete peripheral angle closure.
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Within the first five postoperative days, including day 0 (date of surgery)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence and severity of postoperative dysphotopsia
Periodo de tiempo: between 2 weeks and 1 year postoperatively
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Assessed using a structured dysphotopsia questionnaire based on the instrument by Vera et al., providing an ordinal severity score.
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between 2 weeks and 1 year postoperatively
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Colaboradores e Investigadores
Patrocinador
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Términos relacionados con este estudio
Otros números de identificación del estudio
- DMEK-YAG
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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