CorVision® 4-year Follow-up

NCT07623720 | Completed DMC

• 1 other identifier: CMG-PRT-002-1
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Keywords

microlens; presbyopia; eye surgery; CorVision

Outcome Measures

Primary Outcomes (2)

• Uncorrected Near Visual Acuity of 0.3 logMAR or better

  More than 65% of the eyes should have an Uncorrected Near Visual Acuity (UNVA) of 0.3 logMAR or better at 4 years postoperatively.

  At least 4 years after the implantation

• Implant removal

  The incidence of implant rejection leading to implant removal should occur in no more than 3% of implanted eyes.

  At least 4 years after the implantation

Secondary Outcomes (1)

• Clinically significant corneal haze occurrence

  At least 4 years after the implantation

Other Outcomes (26)

• Monocular Uncorrected Near Visual Acuity at Best Reading Distance

  At least 4 years after the implantation

• Monocular and Binocular Uncorrected Near Visual Acuity at 40 cm

  At least 4 years after the implantation

• Monocular and Binocular Distance Corrected Near Visual Acuity

  At least 4 years after the implantation

Study Arms (1)

Post-presbyopia correction with unilaterally implanted microlens

Presbyopic patients who have undergone implantation of the CorVision microlens according to study protocol CMG-PRT-002.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population are patients who suffered from presbyopia and underwent the original CorVision clinical study are medically suitable to undertake the current clinical study investigation.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gemini Eye Clinic: lead

Study Sites (1)

Gemini Eye Clinic

Zlín, 760 01, Czechia

Location

Related Links

• the protocol of the original study - ClinicalTrials.gov ID: NCT04465409

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gemini Eye Clinic

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 3, 2026
• Study Start: June 27, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CZ (1)