Pseudophakic Bullous Keratopathy Clinical Trial
— PDF DMEKDETACHOfficial title:
Predictive Factors of Graft Detachment Following Dmek: Retrospective Study About 170 Cases
| NCT number | NCT05531760 |
| Other study ID # | 2022-10Obs-CHRMT |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2022 |
| Est. completion date | June 1, 2022 |
| Verified date | September 2022 |
| Source | Centre Hospitalier Régional Metz-Thionville |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of this study was to identify the predictive factors of graft detachment after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This retrospective study was conducted on patients aged 18 years, with Fuchs' dystrophy (FECD) or pseudophakic bullous keratopathy (PBK), who were scheduled for DMEK or triple-DMEK (combined phacoemulsification and DMEK surgery). Patients with a history of surgery other than cataract surgery were excluded. The study was conducted between 2014 and 2022 and follow-up was for 3 months. The characteristics of patients with and without graft detachment following surgery were compared using logistic regression.
| Status | Completed |
| Enrollment | 170 |
| Est. completion date | June 1, 2022 |
| Est. primary completion date | June 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients over 18 years of age with DMEK surgery Exclusion Criteria: - all associated eye surgery other than cataract surgery - all existing anterior segment anomalies |
| Country | Name | City | State |
|---|---|---|---|
| France | CHR Metz-Thionville/Hopital de Mercy | Metz |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Régional Metz-Thionville |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Appearence of the graft on anterior segment optical coherence tomography (AS OCT) examination | clinical examination and anterior segment optical coherence tomography (AS OCT) examination (appearence of the graft) | up to 3 months after surgery |
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