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NCT04072029
Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy
trial testing Phacoemulsification with intraocular lens implantation in Fuchs' Endothelial Dystrophy in 68 participants. Completed in 30 December 2019.
30 December 2019
Quick facts
| Lead sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 68 |
| Start date | 1 July 2017 |
| Primary completion | 30 December 2019 |
| Estimated completion | 30 December 2019 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Phacoemulsification with intraocular lens implantation
Conditions studied
- Fuchs' Endothelial Dystrophy — all drugs for Fuchs' Endothelial Dystrophy →
- Cataract — all drugs for Cataract →
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Who can join
Eligibility, any sex, with Fuchs' Endothelial Dystrophy or Cataract. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Justification. Fuchs' corneal endothelial dystrophy (FECD) is one of the main causes of corneal transplantation. In many cases, the corneal decompensation derived from this dystrophy is triggered as a consequence of cataract surgery, so the dilemma of facing isolated cataract surgery or combined with endothelial keratoplasty is often raised. Objective. The present study aims to evaluate and select the most important predictive factors for corneal decompensation after cataract surgery in patients with FECD. Method. Prospective observational study of the preoperative and intraoperative variables presumably associated with postoperative corneal edema requiring Descemet stripping endothelial keratoplasty (DMEK). Consecutive candidates for cataract surgery with FECD will be selected and anterior segment imaging will be performed, along with a complete ophthalmological examination. Clinical, pachymetric, tmographic, densitometric, specular microscopy, and intraoperative variables will be registered.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04072029
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT05636579 — Study to Assess Safety and Tolerability of Multiple Doses of EO2002 · Phase 1 · recruiting
- NCT05436665 — The Belgian Endothelial Surgical Transplant of the Cornea · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04072029 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Last refreshed: 7 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04072029.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing