Other specified disorders of the cornea
Conditions
Interventions
This is a prospective, open-label, controlled, randomized, single-arm clinical study conducted at a single center (Hospital das Clínicas of the Federal University of Minas Gerais), with follow-up afte
participant selection (enrollment) will follow a sampling-without-replacement scheme, ensuring that the same participant is not included more than once, until the planned number of eligible participan
to minimize bias, investigators record information in standardized forms and an evaluator and, when necessary, a statistician review the data using a segregation-of-activities approach. Procedures, fr
Sponsors
Hospital das Clínicas - Universidade Federal de Minas Gerais
Mediphacos Industrias Médicas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients diagnosed with keratoconus; keratoconus in patients intolerant to contact lenses; pellucid marginal degeneration; decentration of the posterior highest point equal to or greater than 1.25 mm from the center; keratometry with a maximum mean keratometry (Kmean) of 58 µm; minimum corneal thickness of 420 µm in the 5 mm optical zone; both sexes; age 18 years or older; patients willing and able to undergo clinical examinations for follow-up for a period of 1 year after surgery.
Exclusion criteria
Exclusion criteria: Patients without a clinical indication for treatment with intrastromal corneal ring implantation; vulnerable groups, including individuals with reduced or impaired capacity for self-determination, especially with regard to free and informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that improvement in both corrected and uncorrected visual acuity will be observed after BICS (Soft Ring) implantation. This will be verified by comparing corrected and uncorrected visual acuity measurements recorded pre-operatively and at post-operative visits, based on the observation of variations in corrected and uncorrected visual acuity measurements throughout the follow-up period, especially at the 180-day and 360-day post-operative assessments.;It is expected that improvement in both corrected and uncorrected visual acuity will be observed after BICS (Soft Ring) implantation. This will be verified by comparing corrected and uncorrected visual acuity measurements recorded pre-operatively and at post-operative visits, based on the observation of variations in corrected and uncorrected visual acuity measurements throughout the follow-up period, especially at the 180-day and 360-day post-operative assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to identify and characterize the indication for use and potential misuse situations of the intrastromal corneal ring Anel Soft in the clinical setting, verified through standardized recording of procedure data and postoperative follow-up in a case report form, based on the observed number and proportion of occurrences related to indication for use or misuse recorded across follow-up visits;It t is expected to obtain information on the performance of the intrastromal corneal ring Anel Soft over time, including aspects related to device persistence and behavior during follow-up, verified through postoperative clinical follow-up with recording of adverse events and complications, based on the observed number and proportion of participants with adverse events or complications over approximately 12 months after surgery;It is expected to characterize the demographic profile of participants enrolled in the study, verified through collection and recording of demographic data in a case report form, based on descriptive measures and distributions such as age and sex in the evaluated sample;It is expected to characterize comorbidities associated with participants enrolled in the study, verified through collection and recording of medical history and comorbidities in a case report form, based on the observed number and proportion of participants with recorded comorbidities;It is expected to collect and analyze usability data for the intrastromal corneal ring Anel Soft during the study routine, verified through standardized recording of information related to handling, procedure execution, and clinical follow-up in a case report form, based on the observed number and proportion of usability-related records across postoperative visits | — |
Countries
Brazil
Contacts
Public ContactFrederico Bicalho
Mediphacos Industrias Médicas
Outcome results
None listed