Keratoconus
Conditions
Interventions
Retrospective study, with 1 (one) arm, without comparator group. The overall objectives of this post-marketing clinical follow-up study are: to confirm the safety and performance of the Keraring Intra
assess the acceptability of identified risks
and detect emerging risks based on real evidence. The specific objectives are: to confirm the security and performance of Keraring throughout its expected lifetime
confirm that the Keraring Intrastromal Corneal Ring implant is safe for patients, users or others or identify the risks to which they are exposed
identify previously unknown side effects and monitor known side effects and contraindications
identify and analyze emerging risks based on real evidence
ensure the continued acceptability of the benefit-risk balance
identify possible misuse or use in disagreement with the intended indication of the device, in order to verify that the intended use is correct. After the final approval by the Research Ethics Committ
V03.175.500
Sponsors
Mediphacos Indústrias Médicas S.A.
Hospital Oftalmológico de Brasília - HOB
Eligibility
Inclusion criteria
Inclusion criteria: Patient with keratoconus; Both sexes; Any age; Patients who have Keraring implanted in the eye
Exclusion criteria
Exclusion criteria: Patients who do not have Keraring implanted in the eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As for performance, improvement in visual acuity with and without correction is expected after Keraring implantation. For this, visual acuity will be evaluated (visual acuity uncorrected; visual acuity corrected; refractive error; spherical degree; cylindrical degree; k1; k1 axis; k2; k2 axis; astigmatism value; corneal thickness in the thinnest location; largest diameter of the dilated pupil) and a comparison with the preoperative data will be carried out, expecting an increase in visual acuity;As for safety, a low incidence of adverse events, intraoperative and postoperative complications is expected over time. For this, it will be observed if adverse events occurred and the level of postoperative complications (Grade 0; Grade 1; Grade 2; Grade 3; Grade 4; Grade 5). In this way, the incidence of adjustment or reintervention of the corneal intrastromal ring will be monitored; eye cancer; infectious keratitis; sterile keratitis; progressive impairment of vision; corneal melting; corneal damage; epithelial defects; lamellar tunnel deposits or white or white-yellow deposits; localized descemet detachment; vision disorders or night vision disorders; corneal edema; epithelial erosion; recurrent corneal erosion; epithelial edema; corneal intrastromal ring explantation; exposing the tip of the corneal intrastromal ring; corneal intrastromal ring extrusion; fever; photophobia; steroid-induced glaucoma; refractive hypercorrection; epithelial hyperplasia; hypersensitivity or sensitivity; refractive hypocorrection; decentralized corneal intrastromal ring; corneal intrastromal ring is not positioned correctly; inverted implanted corneal intrastromal ring; late or early infection; inflammation around the corneal intrastromal ring; localized infiltrate; eye irritation; glare; migration or displacement of the corneal intrastromal ring; residual nebula in the area where the explanted corneal intrastromal ring was implanted; necrosis; incision opacification; superficial corneal opa | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that the indications for use of the product (keratoconus in contact lens-intolerant patients; post-penetrating keratoplasty astigmatism; corneal ectasia after Lasik; pellucida marginal degeneration; or others) will be correctly met. For this, the evolution of the patient will be evaluated, through the data of the medical records.;It is expected to obtain information about the lifetime of the product. In this way, the statistical analysis will be performed, which will be performed in the R software with the data collected, to be presented in the partial reports in the final report. Student's t-test for paired data will be used to compare pre- and post-operative data (such as visual acuity, keratometry, sphericity, etc.). The chi-square test will be used to compare the rate of intraoperative and postoperative complications. The p value =0.05 will be considered statistically significant. These tests were selected because: (1) Student's t test is indicated for analysis of paired data, it is applied when two or more samples are compared. (2) The chi-square test is indicated for analysis of unpaired data and for testing the adherence of the distribution. (3) The p=0.05 value is the most used risk level in clinical studies and articles abroad; furthermore, it is an acceptable level of risk of making a mistake in rejecting the null hypothesis in a hypothesis test;The Keraring corneal intrastromal ring is expected to meet its indication for use in patients of both sexes and all ages, both adults and children. In this way, demographic data such as gender and age will be collected;It is expected that the product has good usability so that the device is not misused, for this, the usability by the surgeon will be observed, such as the difficulty in handling the cardboard box, the primary packaging, the plastic case, the corneal intrastromal ring and difficulty understanding labels and instructions for use | — |
Countries
Brazil
Contacts
Public ContactGuilherme Rocha
Hospital Oftalmológico de Brasília - HOB
Outcome results
None listed