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Trial registered on ANZCTR


Registration number
ACTRN12623000124639p
Ethics application status
Submitted, not yet approved
Date submitted
28/01/2023
Date registered
7/02/2023
Date last updated
7/02/2023
Date data sharing statement initially provided
7/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of visual outcomes and patient satisfaction after implantation of non-diffractive extended depth of focus and aspheric monofocal intraocular lenses with monovision: a randomised trial
Scientific title
Visual outcomes and patient satisfaction after bilateral implantation of non-diffractive extended depth of focus (RayOne EMV EDoF IOL) and aspheric monofocal (RayOne aspheric IOL) intraocular lenses with monovision strategy for near vision correction among those with senile cataract
Secondary ID [1] 308850 0
None
Universal Trial Number (UTN)
Trial acronym
EMV01
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cataract 328811 0
pseudophakic presbyopia 328812 0
astigmatism 328813 0
Condition category
Condition code
Eye 325821 325821 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total 110 subjects (220 eyes) with bilateral senile cataract, otherwise normal eye, will be recruited and equally randomized into two groups:
Intervention group will receive bilateral implantation of RayOne EMV extended depth-of-focus intraocular lens (IOL). The dominant eye will be implanted with an emmetropic correction, and the non-dominant eye will be targeted for -0.75D to -1.0D post-operative refraction.
Two eye surgeries will be performed at least three weeks apart in both groups.
The surgery will be performed by the principal investigator using a standard phacoemulsification cataract surgical procedure.
Ocular biometry and IOL selection will follow the following procedures:
Biometry measurement: Corneal curvature (Keratometry), axial length, corneal thickness, anterior chamber depth, lens thickness and vitreous chamber depth will be measured using IOL Master 500 (Carl Zeiss Meditec, Germany) at baseline visit. Three consecutive biometry will be performed; the most consistent values measurements as decided by the principal investigator after a careful inspection of the results, will be used for IOL calculation. Biometry will be repeated if needed as prompted by the investigator.
IOL Power Calculation: The European Society of Cataract and Refractive Surgery (ESCRS) online IOL calculator will be used in IOL calculation with the biometry values decided by the principal investigator (preceding section).
IOL Power Selection
Spherical IOL will be implanted in the eyes with pre-operative corneal astigmatism of less than 0.75D as measured by IOL master. For the corneal astigmatism equal to or greater than 0.75D, implantation of toric IOL will be planned.
The spherical equivalent (SE) power of the IOL producing post operative target refraction of emmetropia (closest to zero) will be selected for implantation for the dominant eye and myopia between -0.75D and -1.00D for the non-dominant eye.
Intervention code [1] 325291 0
Treatment: Surgery
Intervention code [2] 325316 0
Treatment: Devices
Comparator / control treatment
Control group will receive bilateral implantation of a standard Rayner aspheric monofocal IOL. The dominant eye will be implanted with an emmetropic correction and the non-dominant eye with -0.75D to -1.0D post-operative target refraction.
Total 55 subjects (110 eyes) will be recruited in this group (with the ratio of 1:1 to the intervention). Surgical procedure, timing between two eye surgery, ocular biometry and IOL power selection will follow exactly the same protocol as in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 333661 0
Primary Outcome 1: Uncorrected monocular near visual acuity
Both monocular and binocular corrected and uncorrected near visual acuities will be tested using Lighthouse continuous reading text test method administered at 40cm and individual’s preferred reading distance. Near vision will be reported using a standardised M-Notation.
Timepoint [1] 333661 0
4 to 6 weeks and 12 to 16 weeks from the second eye surgery
Primary outcome [2] 333662 0
Primary Outcome 2: Distance stereoacuity
The vectographic Randot near and distance stereo tests (Stereo Optical Co, Inc, Chicago, IL, USA) will be used for distance stereoacuity assessment, respectively. The device is validated cyclopean stereo tests. The distance test design consists of four vectographic geometric shapes (circles, triangle, square and star) detectable by disparity. The test is administered at three meters distance and measures 60, 100, 200 and 400 arc seconds (arcsec) stereoacuities.
The testing procedure involves the subject wearing polaroid filter and identifying shapes at each stereoacuity level. Stereoacuities will be recorded in arcseconds; non-measurable stereoacuity will be assigned as ‘nil’.
Timepoint [2] 333662 0
4-6 weeks and 12-16 weeks from the second eye surgery
Primary outcome [3] 333663 0
Primary Outcome 3: Contrast Sensitivity
Contrast sensitivity will be assessed using Mars letter contrast sensitivity method. The test chart contains 48 letters arranged in 8 rows and 6 columns. Each letter subtends 2 degrees of visual angle at 50cm testing distance (2.5 degrees at 40cm). The contrast of each letter, from left to right, continuously decreases by the factor of 0.04 log unit. The procedure involves reading letters from left to right beginning from the top row. The contrast of the final letter before misidentifying two consecutive letters determines the contrast sensitivity as shown in the table.
Timepoint [3] 333663 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [1] 417882 0
Corrected and uncorrected distance Vision
Corrected and uncorrected distance visual acuities will be measured and reported as composite secondary outcomes. This involves measurement of distance acuity with and without correction of residual refractive correction. An electronic visual acuity testing system administered at a >3-metre. Visual acuity will be recorded using logMAR scale. The screen luminance should be 85 to 105 candelas/meter2 and a high contrast (85%) black-on white linearly arranged Sloan letters will be used.
With the room lights on, a linear optotype containing 5 letters will be presented at a time. If error is made in identifying an optotype in a line, the subject will be allowed to reattempt. Threshold visual acuity will be recorded when the subject has incorrect responses for consecutive 2 or more letters. Considering each optotype in every acuity level is valued at 0.02 log unit; each missing optotype will be counted for during determination of the threshold acuity.
Timepoint [1] 417882 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [2] 417883 0
Corrected and uncorrected intermediate vision
Visual acuity at 66cm will be measured monocularly and binocularly; first without correction of residual refractive error followed by with correction. Lighthouse continuous reading text test method will be used and recorded in logMAR scale. The outcome will be assessed and reported as a composite measure.
Timepoint [2] 417883 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [3] 417884 0
Spectacle independence
Spectacle independence will be assessed using self-rated responses to three survey questions. A previous study (Bohm et al 2022) used three light conditions (photopic, high mesopic and low mesopic) and had response scale ranging between 0 and 100. In this study, the responses are modified into frequencies (always, often, sometimes and never).

Do you wear glasses for (spectacle independence) select one of the five frequency options:
distance vision
- always
- frequently
- often
- sometimes
- never
intermediate vision
- always
- frequently
- often
- sometimes
- never
near vision
- always
- frequently
- often
- sometimes
- never
Timepoint [3] 417884 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [4] 417885 0
Symptoms
To assess post-operative visual symptoms, following questionnaire will be administered:
Do you notice following symptoms in your vision?
(Select one frequency of each three symptoms as experienced in indoor and outdoor environment as applicable)

Halo (circle around the light source)
- always (=90% of times)
- frequently (75 – 90% of times)
- often (30 – 75% of times)
- sometimes (10 – 30% of times)
- never (=10% of times)

Glare (difficulty to see in bright light)
- always (=90% of times)
- frequently (75 – 90% of times)
- often (30 – 75% of times)
- sometimes (10 – 30% of times)
- never (=10% of times)

Starburst (star around light source)
- always (=90% of times)
- frequently (75 – 90% of times)
- often (30 – 75% of times)
- sometimes (10 – 30% of times)
- never (=10% of times)
Timepoint [4] 417885 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [5] 417886 0
Patient Satisfaction
Catquest-9SF will be used to assess patient satisfaction in this study. This 9-item Rasch-scaled questionnaire is the validated (Lundstorm & Pesudovs, 2009) and widely used in assessing the patient satisfaction and spectacle independence.
Timepoint [5] 417886 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [6] 417947 0
Primary Outcome 4: Uncorrected monocular and binocular distance visual acuity
Visual acuities (VA), reported as a composite outcome, will be tested with an electronic visual acuity testing system administered at a >3-metre. Visual acuity will be recorded using logMAR scale. The screen luminance should be 85 to 105 candelas/meter2 and a high contrast (85%) black-on white linearly arranged Sloan letters will be used.
With the room lights on, a linear optotype containing 5 letters will be presented at a time. If error is made in identifying an optotype in a line, the subject will be allowed to reattempt. Threshold visual acuity will be recorded when the subject has incorrect responses for consecutive 2 or more letters. Considering each optotype in every acuity level is valued at 0.02 log unit; each missing optotype will be counted for during determination of the threshold acuity.
Timepoint [6] 417947 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [7] 418105 0
Primary Outcome 5: Uncorrected binocular near visual acuity
Binocular corrected and uncorrected near visual acuities will be tested using Lighthouse continuous reading text test method administered at 40cm and individual’s preferred reading distance. Near vision will be reported using a standardised M-Notation.
Timepoint [7] 418105 0
4-6 weeks and 12-16 weeks from the second eye surgery
Secondary outcome [8] 418106 0
Primary Outcome 6: Near stereoacuity
The vectographic Randot near and distance stereo tests (Stereo Optical Co, Inc, Chicago, IL, USA) will be used for near stereoacuity assessment. The validated cyclopean stereo tests device consists of six shapes (circle, square, triangle, star, + & ‘E’) measuring 400 to 20 arc seconds of stereoacuity and is administered at 40cm testing distance.
The testing procedure involves the subject wearing polaroid filter and identifying shapes at each stereoacuity level. Stereoacuities will be recorded in arcseconds; non-measurable stereoacuity will be assigned as ‘nil’.
Timepoint [8] 418106 0
4-6 weeks and 12-16 weeks from the second eye surgery

Eligibility
Key inclusion criteria
- Age 45 years or over
- Pre-operative vision 6/60 or better
- Bilateral senile cataract
- Willing and able to sign informed consent form
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Axial length less than 22.0mm and more than 26.0mm
• Corneal astigmatism greater than 2.50D
• Previous cataract surgery
- History of corneal refractive surgery
- Glaucoma
- Corneal disorders that might affect visual acuity and visual function
- Previous intraocular surgery such as vitrectomy, iridectomy
- Any retinal pathology affecting vision such as: History of amblyopia Anisometropia of more than 2.0D
- Constant strabismus
- Optic nerve and visual pathway pathology
- Intellectual impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure an equal probability of distribution of subject demographics and other variables (not controlled in this study) in each treatment arm, eligible subjects will be randomised and assigned to one of the intervention or control group.
Prior to assignment to a group, a randomisation table will be created using Excel StatPack application. Subjects will then be assigned to a group sequentially as they attend their routine pre-operative visit to the clinic. Recruitment will continue until both groups have reached the required sample size.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Enrolled subjects will be identified using sequential unique identification code (subject ID) consisting of study code (EMV) followed by three-digit enrolment numbers and initials of their first and last name. For example, “EMV-001-PS” where ‘EMV’ is the study code, ‘001’ indicates first enrolled subject (i.e., subject ID) and ‘PS’ indicates initials of the subject’s name (e.g., for Peter Smith).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
STATISTICAL METHODS
All data will be compiled in Excel spreadsheet after checking for data quality and errors. The data will then be transferred into SPSS statistical software for analysis.

Primary Analysis
The primary analysis will involve comparisons of data from 4 to 6 weeks (visit 7) and 12 to 16 weeks (Visit 8) post operative follow up for primary outcome variables including uncorrected and corrected monocular and binocular near vision, stereoacuity and contrast sensitivity. Homogeneity of the data will be checked using Levene’s test for equality of variances and the normal distribution will be examined using Shapiro-Wilk test. If the data is normally distributed, an inferential independent sample t-test will be employed to compare the means of continuous quantitative variables between the groups. If the data are not normally distributed, Wilcoxon’s Test will be utilised. Pearson’s Chi-square test will be used to compare the categorical data of spectacle independence. Descriptive results of the data will be reported using mean, standard deviation, 95% confidence interval and frequency where appropriate. Two-sided probability of less than 5% (p < 0.05) will be considered significant.
Secondary Analysis
The secondary analysis will involve comparison of the secondary outcome variables. Binocular and monocular distance and intermediate vision will be compared using independent sample t-test if the data is normally distributed or Wilcoxon’s test if not normally distributed. Normality of data will be tested using Shapiro-Wilk test. Symptom and patient satisfaction will be compared using Pearson’s Chi-square test. Descriptive results will also be reported as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2023
Actual
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 39363 0
4509 - North Lakes
Recruitment postcode(s) [2] 39364 0
4510 - Caboolture
Recruitment postcode(s) [3] 39365 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 313070 0
Self funded/Unfunded
Name [1] 313070 0
Dr Graham Hay-Smith
Country [1] 313070 0
Australia
Primary sponsor type
Individual
Name
Dr Graham Hay-Smith
Address
Level 2, North Lakes Specialist Medical Centre
6 Northlakes Drive
North Lakes, Queensland 4509
Australia
Country
Australia
Secondary sponsor category [1] 314762 0
Commercial sector/Industry
Name [1] 314762 0
Rayner Ltd UK
Address [1] 314762 0
Rayner, Building 1, Suite E2A, Level 2,
75 O’Riordan Street, Alexandria.
NSW 2015, Australia
Country [1] 314762 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312321 0
Bellberry Ethics Committee
Ethics committee address [1] 312321 0
Ethics committee country [1] 312321 0
Australia
Date submitted for ethics approval [1] 312321 0
10/01/2023
Approval date [1] 312321 0
Ethics approval number [1] 312321 0

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

Contacts
Principal investigator
Name 124242 0
Dr Graham-Hay Smith
Address 124242 0
Level 2,
North Lakes Specialist Medical Centre
6 Northlakes Drive
North Lakes, Queensland 4509
Australia
Country 124242 0
Australia
Phone 124242 0
+61402452393
Fax 124242 0
Email 124242 0
graham.hs@mdhospital.com.au
Contact person for public queries
Name 124243 0
Jit B Ale Magar
Address 124243 0
Queensland Children's Hospital
Level 2b, Ophthalmology
501 Stanley Street
South Brisbane
Queensland 4101
Australia
Country 124243 0
Australia
Phone 124243 0
+61405680461
Fax 124243 0
Email 124243 0
jeetopt@yahoo.com
Contact person for scientific queries
Name 124244 0
Jit B Ale Magar
Address 124244 0
Queensland Children's Hospital
Level 2b, Ophthalmology
501 Stanley Street
South Brisbane
Queensland 4101
Australia
Country 124244 0
Australia
Phone 124244 0
+61405680461
Fax 124244 0
Email 124244 0
graham.hs@mdhospital.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
for privacy and confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



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.