Post-market surveillance study of the Presbia Flexivue Microlens for improvement of near vision in patients with presbyopia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031214

Enrollment

Registered

2023-02-07

Start date

2017-06-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Presbyopia

Interventions

Group 1: Patients receive corneal inlay

Eligibility

Sex/Gender

All

Age

40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. low ametropic presbyopic subjects with addition between +1.5 D and +3.5 D 2. preoperative spherical equivalent of +1.0 D to -0.75 D simultaneously cyl. 20/25 6. Monovision tolerance

Exclusion criteria

Exclusion criteria: 1. Glaucoma, IOP >21mmHg 2. corneal thickness <480µm 3. pathology in the anterior ocular segment 4. corneal diseases 5. subjects with active or recurrent infection of eye or eyelids 6. subjects with chronic dry eye and resistance to therapy 7. subjects with irregular topography 8. subjects with retinal pathologies that affect visual rehabilitation 9. subjects with herpes zoster/simplex in past 10. steroid responders 11. subjects with uncontrolled diabetes or diabetic retinal changes 12. subjects with chronic systemic or topical corticosteroids and immunosuppressive therapie that would affect wound healing

Design outcomes

Primary

Measure	Time frame
Improvement in uncorrected near and intermediate visual acuity	—

Secondary

Measure	Time frame
Complication rate, Change in endothelial cell number	—

Countries

Germany

Contacts

Public ContactThomas Kohnen

Universitätsklinikum Frankfurt der Goethe-Universität Frankfurt

studien@uni-augenklinik-frankfurt.de+496963014752

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026