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Post Market Follow-up Study of Keraring

Post Market Clinical Follow-up Study of Keraring Intrastromal Corneal Ring

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-9qtzsx5
Enrollment
Unknown
Registered
2021-01-29
Start date
2021-02-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Keratoconus

Interventions

This is a mixed cohort clinical study with one (1) arm and no comparator group. The best design for this type of study is a mixed cohort study, to be carried out by collecting retrospective data from

Sponsors

Mediphacos Indústrias Médicas S.A.
Lead Sponsor
Hospital Oftalmológico de Sorocaba/SP
Collaborator

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

MeasureTime frame
It is expected to find improvement in visual acuity with and without correction after Keraring implantation, verified through the collection of anonymized information from the participants' medical records, and the annual collection of postoperative data, such as visual acuity and occurrence of adverse events

Secondary

MeasureTime frame
It is expected to find a low incidence of adverse events, intra and postoperative complications over time, verified through the collection of anonymized information from the participants' medical records, and the annual collection of postoperative data, such as visual acuity and occurrence of adverse events

Countries

Brazil

Contacts

Public ContactAdriana Forseto

Hospital Oftalmológico de Sorocaba/SP

forseto@uol.com.br+55 11 99980-8346

Outcome results

None listed

Source: REBEC (via WHO ICTRP)