Refocus VisAbility™ Micro Insert System Pre-market Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VisAbility™ Micro Insert System.
- Who it may be relevant to
- Registry conditions: Presbyopia. Basic parameters: 45 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Multicenter Clinical Trial To Evaluate The Safety And The Improvement In Near Visual Acuity In Presbyopic Patients Treated With The VisAbility™ Micro Insert System Through 12 Months
Overview
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.
Interventions
- Procedure VisAbility™ Micro Insert System
Surgeon will proceed to VisAbility™ Micro Insert System treatment.
Primary outcome measures
- Primary effectiveness endpoint is improvement of binocular DCNVA at 12 months postoperative. [Time frame: 12 months]
Secondary outcome measures (1)
- Secondary effectiveness endpoint is change in patient quality of life from baseline, as assessed by the NAVQ-P patient questionnaire. [Time frame: 12 months postoperative]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Universitäts-Augenklinik Heidelberg — Heidelberg
Identifiers
NCT: NCT07637500 · VIS-2025