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Trial registered on ANZCTR


Registration number
ACTRN12619001109190
Ethics application status
Approved
Date submitted
26/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of an intraocular lens to provide independence from optical aids at all distances following cataract surgery in patients with astigmatism.
Scientific title
Investigation of AcrySof IQ Panoptix Presbyopia Correcting IOL for subjects with mild to moderate astigmatism
Secondary ID [1] 298848 0
Nil known
Universal Trial Number (UTN)
U1111-1237-5994
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 313801 0
Condition category
Condition code
Eye 312213 312213 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
This study is a prospective consecutive audit of effectiveness following cataract surgery or refractive lens exchange surgery in subjects with pre-existing astigmatism requiring trifocal toric IOL consideration. Patients who have previously undergone routine cataract and intraocular lens replacement with a Panoptix Trifocal Toric IOL will be identified. Patients at 6 months post procedure will be contacted about returning for a review visit (study visit).

Participants will undertake a single visit to confirm the visual acuity (distance, intermediate and near vision), refraction (prescription), defocus curve (best corrected vision at all distances), intraocular lens alignment and patient-reported outcome measurements (to measure vision-related quality of life). These tests will be undertaken by an experienced clinician with 20+ years in conducting ophthalmic examination and clinical trial assessments.

The study requires attendance for a single study visit which is performed at least 6 months from the original uncomplicated procedure.
Intervention code [1] 315116 0
Not applicable
Comparator / control treatment
No control group required.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320852 0
Binocular Uncorrected Near Visual Acuity (40cm)
This represents the level of vision without additional optical aids and is a practical assessment of the efficacy of the intraocular lens. This is achieved by having the patient hold the near vision chart (N notation) at approximately 40cm. The distance will be measured by the technician to ensure consistency. The patient is then asked to read the lowest line possible. The technician observes the patient to ensure no errors are made. This value is recorded.
Timepoint [1] 320852 0
Study visit (between 6 and 12 months following routine cataract removal and insertion of PanOptix Toric Intraocular Lens).
Secondary outcome [1] 373047 0
Percentage within ± 0.25D, 0.50D and 1.0D from intended correction for spherical equivalent (SE) and refractive cylinder
This represents the difference between the intended SE and postoperative SE value. The SE is achieved by obtaining the refraction of the patient. This value is then subtracted from the preoperative estimation. The percentage represents the number of patients within the desired range (e.g. 0.25, 0.5 and 1D).
Timepoint [1] 373047 0
Study visit (between 6 and 12 months following routine cataract removal and insertion of PanOptix Toric Intraocular Lens).
Secondary outcome [2] 373048 0
Mean absolute error (MAE)
The MAE represents the absolute difference in refraction (spherical equivalent or SE) between the estimated SE and the postoperative SE outcome. The MAE will be determined from the medical records, in particular the postoperative refraction and preoperative intraocular lens power calculation.
Timepoint [2] 373048 0
Study visit (between 6 and 12 months following routine cataract removal and insertion of PanOptix Toric Intraocular Lens).
Secondary outcome [3] 373049 0
Toric rotational stability
The intraocular lens is placed at the pre-determined axis at surgery to minimise the existing astigmatism. At the study visit the patient will be seated at the biomicroscopy unit (slit lamp). The slit light is then rotated to align with the toric intraocular lens marks present. This represents the angle of the intraocular lens and is recorded. Lens stability represents the percentage of intraocular lenses that have rotated less than 5 degrees from the surgical axis.
Timepoint [3] 373049 0
Study visit (between 6 and 12 months following routine cataract removal and insertion of PanOptix Toric Intraocular Lens).
Secondary outcome [4] 373050 0
Binocular best distance-corrected (BCD) defocus curve
This represents the intraocular lenses ability to provide visual acuity at various distances. The patient's refraction is placed in a phoropter with both eyes unmasked. The patient is then asked to read the lowest line possible (LogMAR 4m chart) and the value recorded. Additional lenses are added in 0.5D steps and the vision is the re-checked and noted. The range of lenses added is from +2D to -6D. The defocus curve is represented by the visual acuity value at each point (representing virtual distance from the patient).
Timepoint [4] 373050 0
Study visit (between 6 and 12 months following routine cataract removal and insertion of PanOptix Toric Intraocular Lens).
Secondary outcome [5] 373051 0
Safety outcomes
The patient will be asked if they have experienced any visually significant changes or optic phenomena following surgery (e.g. disabling haloes around lights). This will be recorded. Similarly any additional procedures related to the initial surgery will be recorded as a measure of safety.
Timepoint [5] 373051 0
Study visit (between 6 and 12 months following routine cataract removal and insertion of PanOptix Toric Intraocular Lens).

Eligibility
Key inclusion criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
- are more than 40 years of age, of either gender and any race;
- have completed uncomplicated cataract surgery or refractive lens exchange surgery with the Alcon Panoptix Toric IOL at least 6 months prior (but no greater than 12 months)
- regular corneal astigmatism requiring toric IOL correction
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Amblyopia
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
- Macular degeneration
- History of retinal detachment
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A summary of the data will be prepared for measurements prior to, and following surgery. For variables measured on a continuous scale, these summaries will include the sample size, as well as the mean, standard deviation, median, minimum, and maximum. For variables measured on a categorical scale, summaries will provide the number and percentage of subjects who provided each score (or change in scores). These summaries will be provided for all eyes completing the study.

General Statistical Considerations
The statistical analyses will be performed using SPSS, version 24. Statistical significance will be regarded when p < 0.05.

Sample Size Calculation
Sample size estimations were based on the minimum sample needed to achieve 80% power for all hypotheses. An alpha value of 0.05% one-sided was used to account for a simultaneous test of the primary and secondary endpoints, comparing the percentage of patients who have achieved outcomes within a tolerance of the original intended target.

Assuming a standard deviation of 0.18 and a true difference of 0.0 LogMAR (taken from a previous PanOptix study performed by Alcon), the sample size was calculated to be 25.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27316 0
2067 - Chatswood

Funding & Sponsors
Funding source category [1] 303396 0
Commercial sector/Industry
Name [1] 303396 0
Alcon Laboratories
Address [1] 303396 0
15 Talavera Rd, Macquarie Park NSW 2113
Country [1] 303396 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alcon Laboratories
Address
15 Talavera Rd, Macquarie Park NSW 2113
Country
Australia
Secondary sponsor category [1] 303437 0
None
Name [1] 303437 0
Address [1] 303437 0
Country [1] 303437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303925 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 303925 0
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 303925 0
Australia
Date submitted for ethics approval [1] 303925 0
Approval date [1] 303925 0
16/07/2019
Ethics approval number [1] 303925 0
2019/517

Summary
Brief summary
Intraocular lens technology has significantly developed over time to include multifocal and trifocal options. The motivated patient can now readily achieve optical independence for most circumstances. Previously, Alcon have provided the Panoptix Presbyopia Correcting IOL in spherical form only. Residual astigmatism has been shown to decrease unaided visual acuity. As approximately 40% of patients will have corneal astigmatism of 0.75D or greater, this represents a significant cohort of patients that may not adequately benefit from the Panoptix IOL in its current format. (Teresa JCRS 2009) The introduction of a toric option presents a positive opportunity for these patients to optimize their unaided vision at all distances.

The objective of this study is to describe the visual outcomes and safety at minimum 6 months (180 days) post bilateral implantation of the Panoptix Toric IOL. Subject information will be drawn from a single study visit however preoperative and prior surgical information will be collated also.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95274 0
A/Prof Michael Lawless
Address 95274 0
Vision Eye Institute
Level 3 270 Victoria Avenue
Chatswood NSW 2067
Country 95274 0
Australia
Phone 95274 0
+61 2 9424 9999
Fax 95274 0
Email 95274 0
michael.lawless@vei.com.au
Contact person for public queries
Name 95275 0
Dr Chris Hodge
Address 95275 0
Vision Eye Institute
Level 3 270 Victoria Avenue
Chatswood NSW 2067
Country 95275 0
Australia
Phone 95275 0
+61 2 9424 9999
Fax 95275 0
Email 95275 0
christopher.hodge@vei.com.au
Contact person for scientific queries
Name 95276 0
Dr Chris Hodge
Address 95276 0
Vision Eye Institute
Level 3 270 Victoria Avenue
Chatswood NSW 2067
Country 95276 0
Australia
Phone 95276 0
+61 2 9424 9999
Fax 95276 0
Email 95276 0
christopher.hodge@vei.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual outcomes will be provided to the subjects directly.
What supporting documents are/will be available?
Clinical study report
How or where can supporting documents be obtained?
Type [1] 3522 0
Clinical study report
Citation [1] 3522 0
Link [1] 3522 0
Email [1] 3522 0
Other [1] 3522 0
The clinical report of overall study outcomes will be made available to the register at the conclusion of study assessments.
Attachment [1] 3522 0
Summary results
No Results