Clinical trial
Comparison of Two High-Density Silicone Oils in Complicated Rhegmatogenous Retinal Detachment
Name
APEC-0021
Description
The purpose of the study is to compare the safety, intraocular adverse effects and the anatomic and functional outcome with two endotamponade silicone oil after a 3-month in complex inferior retinal re-detachments.
Trial arms
Trial start
2006-08-01
Estimated PCD
2006-08-01
Trial end
2007-08-01
Status
Withdrawn
Phase
Early phase I
Treatment
Oxane HD [oil-RMN3-mixture]
Densiron [(F6H8)
Primary endpoint
visual acuity
anatomical results
Eligibility criteria
Inclusion Criteria:
* Patients complicated persistent retinal detachment due secondary to proliferative vitreoretinopathy
Exclusion Criteria:
* Diabetes
* Uveitis
* Glaucoma
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-06-03
1 organization
2 products
1 indication
Organization
Asociación para Evitar la Ceguera en MéxicoProduct
Oxane HDIndication
Retinal DetachmentProduct
Densiron