Refocus VisAbility™ Micro Insert System Pre-market Clinical Trial

A Prospective, Multicenter Clinical Trial To Evaluate The Safety And The Improvement In Near Visual Acuity In Presbyopic Patients Treated With The VisAbility™ Micro Insert System Through 12 Months

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07637500

Enrollment

Registered

2026-06-09

Start date

2026-06-02

Completion date

2027-12-01

Last updated

2026-09-10

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

Conditions

Presbyopia

Brief summary

The primary study objective is to evaluate the safety and effectiveness of the VisAbility™ Micro Insert System for improvement in binocular distance corrected near visual acuity in presbyopic patients.

Interventions

PROCEDUREVisAbility™ Micro Insert System

Surgeon will proceed to VisAbility™ Micro Insert System treatment.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 60 Years

Healthy volunteers

Inclusion criteria

1. Subjects must be between ages of 45 to 60 at the time of enrolment. 2. Subjects must have best corrected distance visual acuity (BCDVA) of 20/20 in each eye. 3. Subjects must have distance corrected near visual acuity (DCNVA) @ 40 cm of 20/50, 20/63 or 20/80 in each eye. 4. Subjects must have binocular distance corrected near visual acuity (DCNVA) @ 40 cm of 20/50, 20/63 or 20/80.

Exclusion criteria

1. Subjects where either pupil has a baseline percent change from scotopic to photopic of less than 30% or an absolute difference of less than 1.00 mm between scotopic and photopic pupil size as measured by the NeurOptics Pupillometer. 2. Subjects with ocular inflammation, chronic uveitis, or other recurrent anterior or posterior segment inflammatory conditions in either eye; subjects with any ocular or systemic disease(s) posting a significant risk for ocular inflammation, including but not limited to autoimmune disorders (e.g., rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, ulcerative colitis, Crohn's disease, psoriasis, sarcoidosis, Behcet's disease), infections (toxoplasmosis, cat-scratch fe ver, West Nile virus, syphilis, tuberculosis, herpes zoster, herpes simplex, adenovirus), ocular trauma, or gout. 3. Subjects with scleral thickness of less than 530 microns as measured 3.5 to 4.0 mm posterior to the superior temporal quadrant limbus in either eye. 4. Subjects with a history of any prior intraocular procedure (e.g., corneal transplant, filtering procedures for glaucoma, vitrectomy, retinal detachment repair, cataract surgery) or any prior refractive procedure (e.g. LASIK, surface excimer, or incisional surgery) in either eye.

Design outcomes

Primary

Measure	Time frame	Description
Primary effectiveness endpoint is improvement of binocular DCNVA at 12 months postoperative.	12 months	This endpoint will evaluated the improvement of postoperative binocular distance corrected near visual acuity (DCNVA) in 75% of bilaterally implanted subjects at 12 months postoperative

Secondary

Measure	Time frame	Description
Secondary effectiveness endpoint is change in patient quality of life from baseline, as assessed by the NAVQ-P patient questionnaire.	12 months postoperative	The secondary endpoint measures the change in patient quality of life from baseline, as assessed by the NAVQ-P patient questionnaire.

Countries

Germany

Contacts

CONTACTSafia Ayachi

safia@medevise-consulting.com+3388308811

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026