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

Efficacy and safety of three regimens based on tobramycin, dexamethasone and diclofenac for the prevention of pseudophakic macular edema. Randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004416-35-ES

Enrollment

210

Registered

2017-04-18

Start date

2017-04-21

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 19.1 Level: LLT Classification code 100512

Interventions

Trade Name: Tobrex 3 mg/ml Pharmaceutical Form: Ear/eye drops, solution INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Concentration unit: mg/ml milligram(s)/millilitre Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of different treatments based on tobramycin, dexamethasone and diclofenac in the prevention of pseudophakic macular edema.;Secondary Objective: To compare the safety of different treatments based on tobramycin, dexamethasone and diclofenac in the prevention of pseudophakic macular edema. To compare the anatomical and functional results of the different study treatments.;Primary end point(s): Percentage of patients presenting an increase of macular thickness with respect to pres surgery, measured with OCT.;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: To compare the efficacy of different treatments based on tobramycin, dexamethasone and diclofenac in the prevention of pseudophakic macular edema.;Secondary Objective: To compare the safety of different treatments based on tobramycin, dexamethasone and diclofenac in the prevention of pseudophakic macular edema. To compare the anatomical and functional results of the different study treatments.;Primary end point(s): Percentage of patients presenting an increase of macular thickness with respect to pres surgery, measured with OCT.;Timepoint(s) of evaluation of this end point: 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients presenting clinical pseudofakic macular edema. Number of adverse events Best corrected visual acuity Changes in macular thickness Percentage of patients presenting ocular inflammation Changes in the intraocular pressure;Timepoint(s) of evaluation of this end point: 12 weeks	—

Countries

Spain

Contacts

Public ContactOficina de Recerca

Hospital Universitari Parc Taulí

afarre@tauli.cat34937458451

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026