Cataract
Conditions
Interventions
Viscoelastic is used in eye surgeries, mainly in cataract surgeries. Medilon is a viscoelastic manufactured by Mediphacos Indústrias Médicas SA and has been registered with ANVISA (National Health Sur
document usability by the surgeon. For this, this monocular clinical investigation will be carried out in 15 participants, a unicentric, prospective, controlled, non-randomized study, using the viscoe
Sponsors
Oculare Medicina Especializada Ltda
Mediphacos Indústrias Médicas S.A.
Eligibility
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who had a clinical indication for cataract capsular extraction surgery with phacoemulsification with intraocular lens implantation in the posterior chamber. Adult patients 21 years of age or older. Patient with the ability to provide informed consent in the Free and Informed Consent Form approved by the Ethics Committee. Patients willing and able to return for all scheduled follow-up exams for 30 days after surgery.
Exclusion criteria
Exclusion criteria: Mono vision patient. Patient with any anterior segment pathology (examples: keratoconus, dystrophies or significant corneal scarring, guttata, inflammation, edema, dystrophy, etc.) in the eye to be operated. Patient with anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract capsular extraction surgery with posterior chamber Intraocular lens implantation (eg pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the eye to be operated. Patient with any condition that prevents reliable specular microscopy in the eye to be operated on. Patient with uncontrolled glaucoma or glaucoma under treatment. Patient with a history of retinal detachment. Patient with diabetic retinopathy (proliferative or non-proliferative). Clinically significant changes in the pigment epithelium retinal and macula. Severe recurrent anterior or posterior segment inflammation of unknown etiology. Patient with immunodeficiency (infectious, neoplastic or medicated). Patient with chronic use of systemic steroids or immunosuppressive drugs. Patient who participated in any clinical investigation in the eye to be operated within 30 days prior to entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure will be evaluated at different times throughout the study, if it is greater than or equal to 30 mmHg postoperatively, it will be considered as the primary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Throughout the study, the density of endothelial cells will be monitored in the postoperative period compared to the preoperative period, as well as the presence of postoperative inflammation. During the surgical procedure, the usability of the product will be evaluated. | — |
Countries
Brazil
Contacts
Public ContactFrederico Dias da Silva
Outcome results
None listed