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Refocus VisAbility™ Micro Insert System Pre-market Clinical Trial

RecruitingNA

Sponsor: Refocus Group, Inc.

Conditions: Presbyopia

Interventions: VisAbility™ Micro Insert System

Countries: Germany

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 overview

Sex: ALL

Age: 45 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (2)

Bochum, Germany
Heidelberg, Germany