Pseudophakic macular edema
Conditions
Interventions
Trade Name: Cefuroxima NORMON 750mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: CEFUROXIME SODIUM
CAS Number: 56238-63-2
Concentration unit: mg/ml milligram
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
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. -Patients with macular edema in OCT macular preoperatorio proofing whatever the etiology. - Patients with glaucoma treatment with prostaglandin analogsnot been suspended at least one month before the surgery. B. Post-operative: - Intraoperative complications: posterior capsule rupture, vitreous LOST, iris-vitreous incarceration. - Postoperatory complications: lack of compliance of treatment of the sheduled postoperative. - Lack of compliance of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the incidence of macular thickness in patients in the prophylaxis of endophthalmitis realized after cataract surgery not complicated with cefuroxime preparations with that realized with Prokam.;Secondary Objective: To examine the incidence of macular edema and clinically and not clinically significant in both groups of the clinical trial.;Primary end point(s): -Macular thickness(µm), OCT imaged, by OCT Cirrus (Zeiss, Oberkochen, Germany) or Swept Source OCT Triton (Topcon, Tokyo, Japan);Timepoint(s) of evaluation of this end point: Before cataract surgery until 5 +/- 1 weeks after | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Visual acuity by ETDRS test;Timepoint(s) of evaluation of this end point: Before cataract surgery until 5 +/- 1 weeks after | — |
Countries
Spain
Contacts
Public ContactServicio de Oftalmología
Hospital de l'Esperança
Outcome results
None listed