Refocus VisAbility™ Micro Insert System Pre-market Clinical Trial

NCT07637500 | Recruiting

• 1 other identifier: VIS-2025
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary effectiveness endpoint is change in patient quality of life from baseline, as assessed by the NAVQ-P patient questionnaire.

  12 months postoperative

Study Arms (1)

VisAbility™ Micro Insert System

EXPERIMENTAL

Procedure: VisAbility™ Micro Insert System

Interventions

VisAbility™ Micro Insert System PROCEDURE

Surgeon will proceed to VisAbility™ Micro Insert System treatment.

VisAbility™ Micro Insert System

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Refocus Group, Inc.: lead

Study Sites (1)

Universitäts-Augenklinik Heidelberg

Heidelberg, Germany

RECRUITING

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Safia Ayachi

CONTACT

+3388308811; safia@medevise-consulting.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 9, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

DE (1)