Refocus VisAbility™ Micro Insert System Pre-market Clinical Trial

ConditionPresbyopia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-60

SponsorRefocus Group, Inc.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

VisAbility™ Micro Insert System
Procedure/Surgery
Surgeon will proceed to VisAbility™ Micro Insert System treatment.

Treatment groups

33 Participants

are divided into 1 treatment group

Group A: VisAbility™ Micro Insert SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Refocus Group, Inc.

Lead sponsor

Source ClinicalTrials.gov

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