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

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.

Study Overview

• Status: Recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Procedure: VisAbility™ Micro Insert System

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Safia Ayachi; Phone Number: +3388308811; Email: safia@medevise-consulting.com

Study Locations

• Germany
  • Heidelberg, Germany
    • Recruiting
    • Universitäts-Augenklinik Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VisAbility™ Micro Insert System	Procedure: VisAbility™ Micro Insert System; Surgeon will proceed to VisAbility™ Micro Insert System treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary effectiveness endpoint is improvement of binocular DCNVA at 12 months postoperative.	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	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Refocus Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: VIS-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No