Keratoconus
Conditions
Interventions
This post-marketing clinical follow-up study will evaluate the safety and performance of the SG Intrastromal Keraring Corneal Ring model. This prospective, open, non-randomized controlled study with 1
Sponsors
Mediphacos Indústrias Médicas S.A.
Mediphacos Indústrias Médicas S.A.
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with keratoconus; Keratoconus in contact lens-intolerant patients; Pellucid marginal degeneration; decentralization of the highest posterior elevation point = 1.25mm from the center; Keratometry with a maximum mean K of 58µm; Minimum corneal thickness of 420 µm in the 5mm optical zone; both sexes; adults and children; Patients willing and able to perform clinical examinations for follow-up for a period of 1 year after surgery
Exclusion criteria
Exclusion criteria: Patients with no indication for the treatment of intrastromal ring implantation; vulnerable groups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that, in terms of performance, there will be an improvement in visual acuity with and without correction after Keraring implantation. This will be assessed through corrected and uncorrected visual acuity measured with a snellen chart at 6 meters; refraction; assessment of eye condition status by slit lamp (biomicroscopy), comparing pre and postoperative data ;It is expected that, regarding safety, there will be a low incidence of adverse events, intra and postoperative complications over time, and that these will be controlled, for this it will be observed and monitored in postoperative consultations and through corneal tomography exams. and optical coherence tomography which obtains assessment data of anterior and posterior corneal surface elevation, corneal thickness, corneal pachymetry, corneal aberrometry, etc.; and assessment of eye condition status by slit lamp (biomicroscopy) the occurrence and incidence of intrastromal corneal ring adjustment or reintervention; eye cancer; bacterial keratitis; 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; spongiosis; intrastromal corneal ring explantation; exposing the tip of the intrastromal corneal ring; intrastromal corneal ring extrusion; fever; photophobia; steroid-induced glaucoma; refractive hypercorrection; epithelial hyperplasia; hypersensitivity or sensitivity; refractive hypocorrection; decentralized intrastromal corneal ring; intrastromal corneal ring not positioned correctly; inverted implanted intrastromal corneal ring; late or early infection; inflammation around the ring; localized infiltrate; eye irritation; glare; intrastromal corneal ring migration or displacement; residual nebula in the area where t | — |
Secondary
| Measure | Time frame |
|---|---|
| The device is expected to meet its intended indication of use in the treatment of keratoconus in contact lens intolerant patients; post penetrating keratoplasty astigmatism; corneal ectasia after Lasik; pellucid marginal degeneration; or others. For this, the corrected and uncorrected visual acuity will be evaluated, measured with a snellen table at 6 meters; refraction; assessment of the state of the eye condition by slit lamp (biomicroscopy), corneal tomography and optical coherence tomography exams that obtains assessment data of anterior and posterior corneal surface elevation, corneal thickness, corneal pachymetry, corneal aberrometry, etc.; comparing pre- and post-operative data ;Keraring is expected to meet its expected lifetime so that the parameters related to performance, safety and acceptability of the product maintain the specifications established in the product design Intraestromal Keraring Corneal Rings manufactured by Mediphacos during the period established for its validity. For this, the performance of the product, the occurrence of adverse events and the implantation time will be monitored ;Keraring is expected to meet its indication of use, safety and performance in patients of all ages, adults and children, and both sexes. For this, demographic data will be collected from patients and visual acuity tests, slit lamp, optical coherence tomography and corneal tomography will be performed pre and postoperatively, and the occurrence and incidence of adverse events and complications will be monitored ;Keraring is expected to have good usability. In this way, the difficulty in handling the cardboard box, the primary packaging, the plastic case, the intrastromal corneal ring, the difficulty in understanding the labels and instructions for use by the surgeon and whether there was misuse will be evaluated | — |
Countries
Brazil
Contacts
Public ContactJoão Lyra
Logos Saúde LTDA
Outcome results
None listed