VisAbility Micro Insert System for Presbyopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the VisAbility Micro Insert System in presbyopic adults. Eligible participants are 45 to 60 years old with perfect distance vision in both eyes and reduced near vision at 40 cm. The trial focuses on safety and the ability of the device to improve binocular distance-corrected near visual acuity. No phase information is provided. It is conducted at two European eye centers with VisDura, Inc. as the sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruhr University Eye Hospital
  Bochum, Germany Recruiting
• Universitäts-Augenklinik Heidelberg
  Heidelberg, Germany Recruiting

Study contacts

• Study coordinator: Safia Ayachi
• Email: safia@medevise-consulting.com
• Phone: +3388308811

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.