Comparison of macular thickness before and after cataract surgery with an antibiotic from two ways of preparation.

Phase 1

• Conditions: Pseudophakic macular edema; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-001416-11-ES
• Lead Sponsor: Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-10
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 622

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified