CorVision® 4-year Follow-up

Four Years Extended Follow-Up on CorVision® Bioengineered Corneal Microlens: Safety and Efficacy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07623720

Acronym

CorVision4yFU

Enrollment

Registered

2026-06-03

Start date

2025-06-27

Completion date

2025-11-25

Last updated

2026-06-03

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

Conditions

Presbyopia

Keywords

microlens, presbyopia, eye surgery, CorVision

Brief summary

The objective of the study is to assess the long-term safety and effectiveness of the CorVision® microlens implanted in presbyopic patients for the management of management of presbyopia and near vision impairment. Approximately 100 patients in the Czech Republic will participate in this study. The study was reviewed and approved by an independent research ethics committee and also by the State Institute for Drug Control (SÚKL). The study will consist of a single visit during which standard, non-invasive, and painless examinations will be performed. This visit will correspond to the 4-year follow-up visit of the original clinical trial.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Subjects must have undergone implantation of CorVision microlens under study protocol CMG-PRT-002. * Provide informed consent * Willing to participate in the ophthalmological examinations

Exclusion criteria

* Patients with severe ocular or general disorders that would prevent them from completed the visit. * Patients not being able to understand and give informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Uncorrected Near Visual Acuity of 0.3 logMAR or better	At least 4 years after the implantation	More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.
Implant removal	At least 4 years after the implantation	The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.

Secondary

Measure	Time frame	Description
Clinically significant corneal haze occurrence	At least 4 years after the implantation	Clinically significant corneal haze is defined as any new stromal clouding in or near the laser-created pocket that leads to a reduction in central corneal clarity/transparency, is visible upon slit-lamp examination, and is graded as ≥ 2 on a standardized corneal haze grading scale.

Countries

Czechia

Outcome results