Next Generation Cataract and Vitreoretinal Surgery Study

Alcon Research120 enrolled

Overview

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect formal user feedback.

Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Vitreoretinal Disease With or Without Cataracts

Interventions

UNITY Vitreoretinal Cataract SystemDEVICE

UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery

Posterior segment surgery in the operating room with or without simultaneous cataract surgeryPROCEDURE

Posterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery; * Clear media except for cataract and vitreous hemorrhage; * In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag; * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Previous vitrectomy in the operative eye aside from those requiring silicone oil removal; * Neovascular or uncontrolled glaucoma; * Planned glaucoma or postoperative surgeries during study aside from silicone oil removal; * Inadequate pupil dilation (less than 6 millimeters); * Other protocol-defined exclusion criteria may apply.

Locations (5)

NSW Retina Pty Ltd

Hurstville, New South Wales, Australia

Southwest Retina

Liverpool, New South Wales, Australia

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales, Australia

Adelaide Eye & Retina Centre

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"

As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Time frame: Day 0

Secondary Outcomes

Mean Total Time in Eye

The time from first entry into eye/first trocar in to incision closure/last trocar out was measured using a stopwatch and recorded in minutes. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Time frame: Day 0 operative, up to surgery completion

Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"

As reported by the examiner at the Month 3 visit. Intended treatment included macular hole closure, retinal attachment, etc. as applicable for the patient's condition. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Time frame: Month 3 Postoperative

Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3

Visual acuity was assessed with refractive correction in place using a Snellen visual acuity chart. Results were converted to decimal VA, where 2.00 decimal equates to 20/16 Snellen (better than normal distance eyesight), 1.00 decimal equates to 20/20 Snellen (normal distance eyesight), and 0.1 decimal equates to 6/600 Snellen (worse than normal distance eyesight). A positive change value indicates an improvement. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

Data from ClinicalTrials.gov

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