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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04528069




Registration number
NCT04528069
Ethics application status
Date submitted
24/08/2020
Date registered
27/08/2020

Titles & IDs
Public title
Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population
Scientific title
Clinical Investigation of the Visual Outcomes and Safety of AcrySof® IQ PanOptix® Toric Trifocal IOLs in an Asian Population
Secondary ID [1] 0 0
ILX140-P001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphakia 0 0
Corneal Astigmatism 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ACRYSOF® IQ PanOptix® Toric Trifocal IOL
Treatment: Surgery - Cataract surgery

Experimental: PanOptix Toric Trifocal IOL - PanOptix Toric Trifocal IOL implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).


Treatment: Devices: ACRYSOF® IQ PanOptix® Toric Trifocal IOL
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia.

Treatment: Surgery: Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
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
Mean Monocular Residual Manifest Cylinder for All Operative Eyes for All IOL Models Combined
Timepoint [1] 0 0
Month 3 postoperative, Month 6 postoperative
Primary outcome [2] 0 0
Percentage of Eyes With IOL Rotation Less Than 10 Degrees
Timepoint [2] 0 0
Month 3 postoperative, Month 6 postoperative
Primary outcome [3] 0 0
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
Timepoint [3] 0 0
Month 3 postoperative, Month 6 postoperative
Primary outcome [4] 0 0
Mean Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Timepoint [4] 0 0
Month 3 postoperative, Month 6 postoperative
Primary outcome [5] 0 0
Mean Binocular Distance Corrected Near Visual Acuity (DCNVA)
Timepoint [5] 0 0
Month 3 postoperative, Month 6 postoperative
Primary outcome [6] 0 0
Percentage of Eyes With Secondary Surgical Interventions (SSIs), by Category
Timepoint [6] 0 0
Up to Month 6 postoperative
Primary outcome [7] 0 0
Percentage of Subjects With a Severe Visual Disturbance
Timepoint [7] 0 0
Preoperative, Month 3 postoperative, Month 6 postoperative
Primary outcome [8] 0 0
Percentage of Subjects With a Most Bothersome Visual Disturbance (QUVID)
Timepoint [8] 0 0
Preoperative, Month 3 postoperative, Month 6 postoperative
Primary outcome [9] 0 0
Percentage of Subjects With Ocular Serious Adverse Events Including Serious Adverse Device Effects
Timepoint [9] 0 0
Up to Month 6 postoperative
Primary outcome [10] 0 0
Percentage of Subjects With Nonocular Serious Adverse Events Including Serious Adverse Device Effects
Timepoint [10] 0 0
Up to Month 6 postoperative

Eligibility
Key inclusion criteria
Key

* Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);
* Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;
* Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism = 0.50 diopter (D) in both operative eyes;
* Other protocol-defined inclusion criteria may apply.

Key
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Preoperative irregular astigmatism;
* Clinically significant corneal abnormalities;
* Glaucoma;
* History of or current retinal disease; anterior or posterior segment inflammation;
* Other planned ocular surgical procedures including, but not limited to, limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK);
* 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
16/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/12/2021
Sample size
Target
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Alcon Investigator 8117 - Campsie
Recruitment hospital [2] 0 0
Alcon Investigator 7678 - Sydney
Recruitment hospital [3] 0 0
Alcon Investigator 7813 - Footscray
Recruitment hospital [4] 0 0
Alcon Investigator 8122 - Saint Albans
Recruitment postcode(s) [1] 0 0
2194 - Campsie
Recruitment postcode(s) [2] 0 0
2150 - Sydney
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
3021 - Saint Albans

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Clinical Trial Lead, CDMA 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04528069