A Clinical Trial of The VisAbility Micro Insert System for Presbyopic

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of the VisAbility Micro Insert System for the improvement of near visual acuity in presbyopic patients.

Clinical Trial Description

The objective of this study is to evaluate the safety and effectiveness of the VisAbility Implant System (VIS) for the improvement of near visual acuity in presbyopic patients. This is a prospective clinical study that enrolled a total of 360 subjects ranging in age between 45 and 60 years of age at 13 clinical sites. Subjects were implanted with the VisAbility Implant model SGP-046 in the primary eye and then in the fellow eye no sooner than 14 days later. Subjects were examined at one day, one week and at 1, 2, 3, 6, 12, 18 and 24 months post-operatively.

The study also included a 60 subject randomized controlled sub-study at 3 investigation sites. Sub-study subjects were randomized (1:1 ratio) to a surgery group or a control group. Subjects randomized to the surgery group underwent surgery and were followed for 24 months in the same manner as the larger non-randomized surgical group. Subjects randomized to the control group were observed for 6 months, and were then eligible to undergo surgery after completion of this 6-month observation period.

The primary endpoint is the achievement of distance corrected near visual acuity (DCNVA) of Snellen equivalent 20/40 or better (at 40 cm) and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.

This endpoint is evaluated against two objectives, a) 75% or more of primary eyes achieve the effectiveness endpoint at 12 months postoperative and b) the percentage of primary eyes achieving the effectiveness endpoint at 6 months postoperative (6-month responder rate) is higher than the percentage in the randomized control group.

Safety data analyses were performed and separate summaries are provided for primary and all eyes. Descriptive statistics on the following attributes are provided for; BCDVA, IOP, Slit lamp findings, Fundus exam findings, and Adverse events. ;

Study Design

Related Conditions & MeSH terms

Presbyopia

Clinical Trial Details

NCT number	NCT02374671
Study type	Interventional
Source	Refocus Group, Inc.
Contact
Status	Completed
Phase	N/A
Start date	November 15, 2014
Completion date	April 13, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05326607` - Pilot Clinical Investigation of Adaptative Eyeglasses for the Correction of Presbyopia	N/A
Recruiting	`NCT06060041` - IC-8 Apthera IOL New Enrollment Post Approval Study
Completed	`NCT05495971` - Extended Depth of Focus Contact Lenses for Presbyopia	N/A
Completed	`NCT05464732` - Vivity IOL: Emmetropia Compared to Monovision.	N/A
Recruiting	`NCT06045299` - Evaluation of the Efficacy and Safety of LNZ101 and LNZ100 for the Presbyopia	Phase 3
Active, not recruiting	`NCT04151550` - Safety & Efficacy of the Laser Scleral Microporation Procedure (Philippines)	N/A
Not yet recruiting	`NCT05506553` - Comparison of Aspheric Toric Intraocular Lenses for Micro-monovision	N/A
Completed	`NCT02554396` - Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia	Phase 2
Completed	`NCT02214797` - Dispensing Study to Assess Visual Performance of Prototype Contact Lenses	N/A
Completed	`NCT02235831` - DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance	N/A
Enrolling by invitation	`NCT01443585` - Clinical Evaluation of a Progressive Addition Lens (PAL)	N/A
Completed	`NCT01591499` - Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal	N/A
Completed	`NCT04983589` - A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily	Phase 3
Completed	`NCT02740010` - The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
Recruiting	`NCT05796453` - Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix	N/A
Completed	`NCT02516306` - A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia	Phase 1/Phase 2
Completed	`NCT05359380` - The Impact of Light Conditions on the Efficacy of Multifocal Intraocular Lens Implantation in Activities of Daily Living
Not yet recruiting	`NCT04522427` - Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery	N/A
Completed	`NCT03688425` - Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes	N/A
Recruiting	`NCT06053463` - Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Clinical Trial of The VisAbility Micro Insert System for Presbyopic Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms