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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
27/08/2024

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:
Ophthalmic Surgery 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 VCS
Treatment: Surgery - Eye surgery

Experimental: UNITY VCS - Eye surgery performed with UNITY VCS


Treatment: Devices: UNITY VCS
Investigational device used during anterior and posterior segment ophthalmic surgery.

Treatment: Surgery: Eye surgery
Eye surgery performed with UNITY VCS
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?"
Timepoint [1] 0 0
Day 0 operative
Secondary outcome [1] 0 0
Total time in the eye
Timepoint [1] 0 0
Day 0 operative
Secondary outcome [2] 0 0
Percent of 'yes' responses to the binary question, "Was anatomical success achieved for intended treatment (e.g., macular hole closure, retinal attachment, etc. as applicable for the patient's condition)?"
Timepoint [2] 0 0
Month 3 Postoperative
Secondary outcome [3] 0 0
Change from preoperative in Best Corrected Distance Visual Acuity (BCDVA) at Month 3 postoperative
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
119
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Retina and Macula Specialists - Hurstville
Recruitment hospital [2] 0 0
Retina Associates - 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 hospital [6] 0 0
St John of God Eye Centre - Geelong
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
Recruitment postcode(s) [6] 0 0
3220 - Geelong

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability and to collect formal user feedback.
Trial website
https://clinicaltrials.gov/study/NCT06165744
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06165744