NCT07637500 VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
| NCT ID | NCT07637500 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VisDura, Inc. |
| Condition | Presbyopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2026-06-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07637500 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 60 Years, studying Presbyopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07637500 currently recruiting?
Yes, NCT07637500 is actively recruiting participants. Contact the research team at safia@medevise-consulting.com for enrollment information.
Where is the NCT07637500 trial being conducted?
This trial is being conducted at Bochum, Germany, Heidelberg, Germany.
Who is sponsoring the NCT07637500 clinical trial?
NCT07637500 is sponsored by VisDura, Inc.. The trial plans to enroll 33 participants.