Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000221550
Ethics application status
Approved
Date submitted
25/01/2024
Date registered
6/03/2024
Date last updated
6/03/2024
Date data sharing statement initially provided
6/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcome of Clareon Toric Intraocular Lens Implantation in Cataract Patients
Scientific title
Retrospective chart review of Clareon Toric Intraocular Lens Outcomes in Patients Who Underwent Routine, Uncomplicated Cataract Surgery
Secondary ID [1] 311409 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 332689 0
Condition category
Condition code
Eye 329401 329401 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention/exposure is being performed. This is a retrospective chart review of visual and intraocular lens performance in patients who underwent routine, uncomplicated cataract surgery between January 2021 and October 2023 by a single surgeon.
Intervention code [1] 327848 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337215 0
Best Corrected Visual Acuity
Timepoint [1] 337215 0
One month after cataract surgery
Secondary outcome [1] 431084 0
Refractive Outcome
Timepoint [1] 431084 0
One month after cataract surgery
Secondary outcome [2] 431085 0
Residual refractive astigmatism
Timepoint [2] 431085 0
One month after cataract surgery
Secondary outcome [3] 431086 0
Mean residual spherical equivalent refractive error
Timepoint [3] 431086 0
One month after cataract surgery
Secondary outcome [4] 431087 0
Uncorrected distance visual acuity
Timepoint [4] 431087 0
One month after cataract surgery
Secondary outcome [5] 431088 0
Monocular intermediate unaided visual acuity
Timepoint [5] 431088 0
One month after cataract surgery
Secondary outcome [6] 431089 0
Surgically induced astigmatism
Timepoint [6] 431089 0
One month after cataract surgery
Secondary outcome [7] 431090 0
Comparison of refractive outcome depending on cylinder power of toric intraocular lens
Timepoint [7] 431090 0
One month after cataract surgery
Secondary outcome [8] 431091 0
Rotational stability of toric IOL
Timepoint [8] 431091 0
From end of surgery to day one, week one and month one post-operatively.
Secondary outcome [9] 431092 0
Assessment for adverse events including intraoperative such as posterior capsule rupture, as well as post-operative including but not limited to endophthalmitis, cystoid macula oedema, inflammatory cells in the anterior chamber, dry eye and corneal oedema.
Timepoint [9] 431092 0
At any point in the first month after surgery and including the surgery itself.
Secondary outcome [10] 432006 0
Monocular Distance Corrected Intermediate Visual Acuity
Timepoint [10] 432006 0
One month post-operative

Eligibility
Key inclusion criteria
Eyes undergoing routine cataract surgery requiring implantation of a Clareon monofocal toric intraocular lens.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous ocular surgery, ocular pathology limiting visual outcome, other health issues limiting ability to attain subjective refraction such as dementia.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/01/2024
Date of last participant enrolment
Anticipated
Actual
25/01/2024
Date of last data collection
Anticipated
Actual
25/01/2024
Sample size
Target
100
Accrual to date
Final
161
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26081 0
Adelaide Eye and Laser Centre - Eastwood
Recruitment postcode(s) [1] 41936 0
5063 - Eastwood

Funding & Sponsors
Funding source category [1] 315671 0
Commercial sector/Industry
Name [1] 315671 0
Alcon
Country [1] 315671 0
United States of America
Primary sponsor type
Individual
Name
Ben LaHood
Address
Country
Australia
Secondary sponsor category [1] 317773 0
None
Name [1] 317773 0
Address [1] 317773 0
Country [1] 317773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314548 0
Bellberry Human Research Ethics Committee E
Ethics committee address [1] 314548 0
Ethics committee country [1] 314548 0
Australia
Date submitted for ethics approval [1] 314548 0
29/11/2023
Approval date [1] 314548 0
02/01/2024
Ethics approval number [1] 314548 0
2023-11-1350

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

Contacts
Principal investigator
Name 131978 0
Dr Ben LaHood
Address 131978 0
Adelaide Eye and Laser Centre 215 Greenhill Road, Adelaide 5063
Country 131978 0
Australia
Phone 131978 0
+61 451545323
Fax 131978 0
Email 131978 0
[email protected]
Contact person for public queries
Name 131979 0
Ben LaHood
Address 131979 0
Adelaide Eye and Laser Centre 215 Greenhill Road, Adelaide 5063
Country 131979 0
Australia
Phone 131979 0
+61 451545323
Fax 131979 0
Email 131979 0
[email protected]
Contact person for scientific queries
Name 131980 0
Ben LaHood
Address 131980 0
Adelaide Eye and Laser Centre 215 Greenhill Road, Adelaide 5063
Country 131980 0
Australia
Phone 131980 0
+61 451545323
Fax 131980 0
Email 131980 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21484Ethical approval    387230-(Uploaded-25-01-2024-07-20-31)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.