EUCTR2017-001416-11-ES
Active, not recruiting
Phase 1
Assessment of macular thickness after non-traumatic cataract surgery associated to intracamerular injection of Cefuroxima prepared at the hospital vs Prokam.
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)0 sites622 target enrollmentAugust 10, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
- Enrollment
- 622
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults patients of both genres aged between 18 and 99 years.
- •Patients with cataracts 2 or 3 graded,by the Established in the
- •classification of LOCS III.
- •Patients who have signed inform consent indicating that they have
- •been informed regarding all
- •the clinical trial aspects, or in the event that the subjects of the trial are
- •incapacitated, signature of consent by the family member or legally
- •designated representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •A. preoperative:
- •\-Alergia or hypersensitivity to ß\-lactámic antibiotic or to any of the
- •excipients of the clinical trial drugs.
- •\-Pacientes with no proliferative diabetic retinopathy, moderate or
- •severe diabetic macular edema or diabetic retinopathy proliferation
- •(any grade).
- •\- History of uveitis, macular degeneration associate in the Middle (AMD)
- •type of exudative or atrophic, diabetic retinopathy, vein occlusion or
- •central retinal vein branch, epiretinal membrane (SEM) and retinitis
- •pigmentosa.
Outcomes
Primary Outcomes
Not specified
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