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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06165744




Registration number
NCT06165744
Ethics application status
Date submitted
4/12/2023
Date registered
11/12/2023
Date last updated
25/06/2025

Titles & IDs
Public title
Next Generation Cataract and Vitreoretinal Surgery Study
Scientific title
Next Generation Cataract and Vitreoretinal Surgery Study
Secondary ID [1] 0 0
CTV678-E001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitreoretinal Disease With or Without Cataracts 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - UNITY Vitreoretinal Cataract System
Treatment: Surgery - Posterior segment surgery in the operating room with or without simultaneous cataract surgery

Experimental: UNITY VCS - Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS


Treatment: Devices: UNITY Vitreoretinal Cataract System
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

Treatment: Surgery: Posterior segment surgery in the operating room with or without simultaneous cataract surgery
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).
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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?"
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Day 0
Secondary outcome [1] 0 0
Mean Total Time in Eye
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Day 0 operative, up to surgery completion
Secondary outcome [2] 0 0
Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Month 3 Postoperative
Secondary outcome [3] 0 0
Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Preoperative (Day -30 to 0), Month 3 Postoperative

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2024
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
NSW Retina Pty Ltd - Hurstville
Recruitment hospital [2] 0 0
Southwest Retina - Liverpool
Recruitment hospital [3] 0 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment hospital [4] 0 0
Adelaide Eye & Retina Centre - Adelaide
Recruitment hospital [5] 0 0
Pennington Eye Clinic - North Adelaide
Recruitment postcode(s) [1] 0 0
2220 - Hurstville
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alcon Research
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Clinical Operations Lead, Surgical
Address 0 0
Alcon Research, LLC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT06165744