Comparative study of different therapeutic regimens based on tobramycin, dexamethasone and diclofenac for the prevention of macular edema after cataract surgery.

Phase 1

Conditions: Pseudophakic macular edema is a pathology that results from cataract surgery, usually occurring 4-6 weeks after surgery, which directly affects the retina (specifically the macula, the region that provides maximum visual acuity). In this condition, for different reasons, an inflammatory exudate accumulates in the different layers of the retina and can lead to affect the visual acuity, to severe retinal alterations both acute or chronic.
MedDRA version: 19.1Level: LLTClassification code 10051240Term: Cystoid macular edemaSystem Organ Class: 100000004853
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2016-004416-35-ES

Lead Sponsor: Fundació Parc Taulí

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients between 35-85 years
2. Patients with cataract in any of their forms that are submitted to intervention under phacoemulsification and intraocular lens implantation.
3. Patients who give their informed consent to participate in the study.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

1. Diabetic patients.
2. Patients with known previous macular pathology.
3. Patients with previous eye surgery in the eye to intervene.
4. Patients with cystic macular edema prior to surgery.
5. Pregnant or lactating women.
6. Patients unable to administer the treatment correctly.
7. Patients with any contraindication to the study treatments according to the approved technical data sheets.
8. Any circumstance that at the discretion of the physician may pose a risk or clinical harm to the patient's participation in the study or interfere with the assessments of the same.