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RecruitingNCT07637500Updated Oct 15, 2026

VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial

An interventional study of VisAbility™ Micro Insert System in Presbyopia, sponsored by VisDura, Inc.. Recruiting at 2 sites in Germany. Open to participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by VisDura, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Updated Oct 15, 2026Sponsor changedTitle changed+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
45 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Presbyopia

Browse trials for

03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 33 is below the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

This is the only study on the registry with VisDura, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    VisAbility™ Micro Insert System

    Procedure: VisAbility™ Micro Insert System

Interventions

  • ProcedureVisAbility™ Micro Insert System

    Surgeon will proceed to VisAbility™ Micro Insert System treatment.

06

What researchers measure

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

    Time frame: 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.

    The secondary endpoint measures the change in patient quality of life from baseline, as assessed by the NAVQ-P patient questionnaire.

    Time frame: 12 months postoperative

07

Study locations

2 of 2 sites recruiting
  • Ruhr University Eye Hospital
    Bochum, Germany
    Recruiting
  • Universitäts-Augenklinik Heidelberg
    Heidelberg, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.

Of 87 industry-sponsored interventional studies with no phase under Presbyopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's planned 18 months is above that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2026
First posted
Jun 9, 2026
StartActual
Jun 2, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Ruhr University Eye Hospital · Bochum, Germany
Show 1 removed
  • Refocus Clinical Site · Bochum, Germany
Oct 15, 2026
Title
RefocusVisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Oct 15, 2026
Sponsor
Refocus Group, Inc.→VisDura, Inc.
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    1 site added, 1 site removed
    Show site
    • Ruhr University Eye Hospital · Bochum, Germany
    Show 1 removed
    • Refocus Clinical Site · Bochum, Germany
    Sponsor Refocus Group, Inc.→VisDura, Inc.
    Title RefocusVisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07637500
Lead sponsor
VisDura, Inc.
Responsible party
Sponsor
First posted
Jun 9, 2026
Start date
Jun 2, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Safia Ayachi
Contact
safia@medevise-consulting.com
+3388308811

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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