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Trial registered on ANZCTR


Registration number
ACTRN12624000490572
Ethics application status
Approved
Date submitted
1/03/2024
Date registered
22/04/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
22/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate and Compare Performance and Safety of the HOYA Vivinex™ Gemetric™ Plus Toric Preloaded Intraocular Lens (IOLs) with the Alcon AcrySof® IQ PanOptix® Toric Trifocal IOLs
Scientific title
A Prospective, Randomised Investigation to Evaluate and Compare Performance and Safety of the HOYA Vivinex™ Gemetric™ Plus Toric Preloaded IOLs with the Alcon AcrySof® IQ PanOptix® Toric Trifocal IOLs in adults planned for cataract surgery and implantation of IOLs
Secondary ID [1] 311550 0
GEMT-104-HIGH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataracts 332910 0
Condition category
Condition code
Eye 329625 329625 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigational device: HOYA Vivinex™ Gemetric™ Plus Toric preloaded IOL, Model XY1-GPT2, XY1-GPT3, XY1-GPT4, XY1-GPT5, XY1-GPT6.

The investigational devices will be used in the proposed clinical investigation according to the instructions for use. The IOL is indicated for the visual correction of aphakia and pre-existing corneal astigmatism after implantation in the capsular bag in adult patients.
The IOL is indicated for use in adult cataract patient only.

The implantation of the IOL will be at the same time as the cataract surgery. Subjects will be implanted monocularly with the investigational or comparator lens in the study eye. The eligible eye will be the study eye. Should both eyes be eligible, the study eye will be the right eye (OD). However, any planned cataract surgery required for fellow eye will need to be done at least 2 weeks after and preferably within 3 months of the study eye surgery. No study specific procedure on fellow eye except for recording IOL information (name, manufacturer, mono-/bi-/multi-focal/others) and surgery timing for the fellow eyes in eCRF, if applicable.

Ophthalmic surgeons who have completed a residency in ophthalmology or its documented equivalent and are licensed to practice medicine and perform surgery at an investigative site will administer the IOL. Investigators for this clinical trial will be selected from surgeons who are experienced in small-incision phacoemulsification and IOL implantation in cataract patients and having experience with HOYA or similar preloaded IOLs.

Power range of the lens models:
Spherical power: +10.00D to +30.00D (in 0.50 D increments)
Addition Power: +3.50D (near), +1.75D (intermediate)
Cylinder Power (IOL Plane): XY1-GPT2: 1.00D, XY1-GPT3 to XY1-GPT6: 1.50D to 3.75D (0.75D step)

The investigational device will be implanted into the capsular bag of eye and remain there. Participants will be followed-up for 12 months to demonstrate clinical performance, effectiveness and safety.
Intervention code [1] 328003 0
Treatment: Devices
Comparator / control treatment
ALCON AcrySof® IQ PanOptix® Toric Trifocal IOL (i.e., PanOptix Toric), model TFNT20, TFNT30, TFNT40, TFNT50, TFNT60

The implantation of the IOL will be at the same time as the cataract surgery. Subjects will be implanted monocularly with the investigational or comparator lens in the study eye. The eligible eye will be the study eye. Should both eyes be eligible, the study eye will be the right eye (OD). However, any planned cataract surgery required for fellow eye will need to be done at least 2 weeks after and preferably within 3 months of the study eye surgery. No study specific procedure on fellow eye except for recording IOL information (name, manufacturer, mono-/bi-/multi-focal/others) and surgery timing for the fellow eyes in eCRF, if applicable.

Power range of the lens models:
Spherical power: 6.0 D ~ 30.0 D in 0.5 D increments; 31.0 D ~ 34.0 D in 1.0 D increments
Addition Power: 2.17 D intermediate and a +3.25 D near add power at the IOL plane (representing approximately +1.65 D and +2.35 D at the corneal plane after implantation, respectively, for an average human eye)
Cylinder Power (IOL Plane): TFNT20: 1.00 D, TFNT30: 1.50 D, TFNT40: 2.25 D, TFNT50: 3.00 D, TFNT60: 3.75 D

The comparator device will be implanted into the capsular bag of eye and remain there. Participants will be followed-up for 12 months.
Control group
Active

Outcomes
Primary outcome [1] 337414 0
Percentage of participants achieving 0.3 LogMAR monocular Distance Corrected Near Visual Acuity (DCNVA) at 40cm at 6-month visit (150-210 days postoperative) for the study eye.
Timepoint [1] 337414 0
6-months (150-210 days postoperative)
Secondary outcome [1] 431775 0
Monocular DCNVA (40cm)
Timepoint [1] 431775 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [2] 431776 0
Monocular DCNVA (33cm) at postoperative 6/12 month visit
Timepoint [2] 431776 0
Postoperative 6 and 12 month visits
Secondary outcome [3] 431777 0
Monocular Uncorrected Near Visual Acuity (UNVA) (40cm)
Timepoint [3] 431777 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [4] 431778 0
Manifest refraction spherical equivalent (target MRSE vs postoperative MRSE) to achieve emmetropia within ± 0.3 D for the study eyes
Timepoint [4] 431778 0
Postoperative 3, 6 and 12 month visits
Secondary outcome [5] 431779 0
Presence of visual disorders or other optical visual phenomenon
Timepoint [5] 431779 0
Postoperative 6 and 12 month visits
Secondary outcome [6] 431799 0
Safety - Corneal appearance (under slit lamp)
Timepoint [6] 431799 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [7] 431801 0
Safety - Corneal endothelial cell count
Timepoint [7] 431801 0
Postoperative 3, 6 and 12 month visits
Secondary outcome [8] 431803 0
Safety - Fundus condition
Timepoint [8] 431803 0
Postoperative 1 week, 1, 6 and 12 month visits
Secondary outcome [9] 432239 0
After-cataract (posterior capsular opacification)
Timepoint [9] 432239 0
Postoperative 1, 6 and 12 month visits
Secondary outcome [10] 432240 0
Incidence of secondary surgical intervention (SSI) due to any reason during the study
Timepoint [10] 432240 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [11] 432241 0
Occurrence of complications, adverse event rates, adverse device effects, device deficiencies. Examples of ocular serious adverse events that are anticipated: Endophthalmitis/Intraocular infection, Hypopyon, Hyphema, IOL dislocation from posterior chamber, Persistent cystoid macular edema, Pupillary block, Retinal detachment/tear, Persistent corneal edema, Persistent iritis, Persistent raised IOP requiring treatment, Axis misalignment requiring secondary surgical intervention (e.g., repositioning), Tilt, decentration, dislocation and rotation requiring secondary surgical intervention (e.g., repositioning), Residual refractive error resulting in a secondary surgical intervention, Residual lens remnants resulting in a secondary surgical intervention, Visual symptoms requiring secondary surgical intervention
Timepoint [11] 432241 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [12] 432956 0
Safety - Intraocular pressure (IOP)
Timepoint [12] 432956 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [13] 432957 0
Safety - Intraocular lens performance
Timepoint [13] 432957 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [14] 432961 0
Safety - Inflammatory reaction in anterior and posterior segments
Timepoint [14] 432961 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [15] 433197 0
Distance Corrected Intermediate Visual Acuity (DCIVA) (66cm)
Timepoint [15] 433197 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [16] 433198 0
Corrected Distance Visual Acuity (CDVA) (4m)
Timepoint [16] 433198 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [17] 433199 0
Uncorrected Intermediate Visual Acuity (UIVA) (66cm)
Timepoint [17] 433199 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [18] 433200 0
Uncorrected Distance Visual Acuity (UDVA) (4m)
Timepoint [18] 433200 0
Postoperative 1 day, 1 week, 1, 3, 6 and 12 month visits
Secondary outcome [19] 433969 0
Presence of visual disorders or other optical visual phenomenon
Timepoint [19] 433969 0
Postoperative 6 and 12 month visits

Eligibility
Key inclusion criteria
1. Adult subjects with a minimum age of 18 years
2. Planned for unilateral or bilateral cataract surgery and implantation of IOLs
3. Pre-operative regular corneal astigmatism greater than 0.75 diopter (D) requiring treatment with the toric models of the study lens
4. Clear intraocular media other than cataract
5. Expected postoperative corrected distance visual acuity of 0.3 logMAR or better
6. Subjects who require a spherical equivalent lens power from +10.00D to +30.00D and a maximum toric lens power of +3.75D at IOL plane
7. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants shall not be/ not have:
1. Preoperative CDVA better than 0.3 LogMar (< 0.3 LogMAR) assessed by ETDRS visual chart
2. Corneal endothelial cell count < 2000 cells/mm2
3. Intraocular inflammation or recurrent ocular inflammatory condition
4. Previous intraocular or corneal surgery (e.g. LASIK, LASEK, RK, PRK, etc.), including corneal refractive surgery, or retinal surgery excluding laser treatment of peripheral retinal regions not affecting vision in the opinion of the investigator
5. Lentodonesis2 or other capsular bag pathologies (e.g., after traumatic cataract)
6. Strabismus, amblyopia, or single eye status,
7. Pupil abnormalities (e.g., non-reactive, fixed pupils, or abnormally shaped pupils)
8. Keratoconus or irregular corneal astigmatism as estimated by surgeon (e.g., angle steep/flat not equal to 90° in 3mm zone; asymmetric power distribution)
9. Continuous contact lens wearing within 6 months of the preoperative examination for PMMA contact lenses, within 1 month of the preoperative examination for gas permeable lenses, or within 3 weeks of the preoperative examination for extended-wear and daily-wear soft contact lenses
10. Presence of corneal pathology affecting topography (e.g., stromal, epithelial or endothelial dystrophy)
11. Previous retinal detachment or vitreous detachment impacting visual acuity and/or requiring treatment
12. Acute, chronic, or uncontrolled systemic or ocular disease or illness in the opinion of the investigator that would increase the operative risk or confound the outcome of the clinical investigation (e.g., poorly-controlled diabetes, immuno-compromised, connective tissue disease, uncontrolled ocular hypertension, glaucomatous changes on the optic nerve, chronic iritis/uveitis, retinal vessel disease, etc.) or where healing processes are compromised
13. Diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) or known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the clinical investigation (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
14. Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
15. Use of systemic or ocular medications that may affect vision
16. Serious dry eye symptoms that could lead to refractive changes/fluctuations and to significant subjects’ complaints
17. Prior or current use of any medication (e.g., a1-blocker such as tamsulosin or silodosin) likely, in the opinion of the investigator, to cause poor dilation or lack of adequate iris structure or floppy iris syndrome to perform standard cataract surgery
18. Inability to focus, fixate or maintain binocular vision for prolonged periods of time (e.g., due to strabismus, nystagmus, Parkinson disease, etc.)
19. Pregnant, plan to become pregnant, lactating or have another condition associated with the fluctuation of hormones that could lead to significant refractive changes
20. Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days

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)
Random codes will be generated by SAS 9.4. Interactive Response Technology (IRT). Randomisation is by central randomisation by computer. A subject will be randomised and assigned to a specific clinical investigation arm after confirmation of eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random codes will be generated by SAS 9.4. Interactive Response Technology (IRT). Randomisation will be stratified by the investigational site.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment outside Australia
Country [1] 26148 0
Philippines
State/province [1] 26148 0
Country [2] 26149 0
Singapore
State/province [2] 26149 0
Country [3] 26150 0
China
State/province [3] 26150 0

Funding & Sponsors
Funding source category [1] 315845 0
Commercial sector/Industry
Name [1] 315845 0
HOYA Medical Singapore Pte. Ltd.
Country [1] 315845 0
Singapore
Primary sponsor type
Commercial sector/Industry
Name
HOYA Medical Singapore Pte. Ltd.
Address
Country
Singapore
Secondary sponsor category [1] 317990 0
Commercial sector/Industry
Name [1] 317990 0
Pharmaceutical Solutions Australia Pty Ltd
Address [1] 317990 0
Country [1] 317990 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314701 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 314701 0
https://bellberry.com.au/
Ethics committee country [1] 314701 0
Australia
Date submitted for ethics approval [1] 314701 0
28/02/2024
Approval date [1] 314701 0
01/05/2024
Ethics approval number [1] 314701 0

Summary
Brief summary
The purpose of this clinical investigation is to confirm the clinical performance and safety of the HOYA Vivinex™ Gemetric™ Plus Toric preloaded IOLs versus comparator Alcon Acrysof® IQ PanOptix® Toric Trifocal IOLs. The medical indication is the implantation with a Vivinex™ Gemetric™ Plus Toric preloaded IOL for visual correction of aphakia and pre-existing corneal astigmatism after implantation into the capsular bag in adult patients who desire near, intermediate and distance vision with increased spectacle independence.

The primary hypothesis is based on the primary performance endpoint, that is the percentage of patients achieving 0.3 LogMAR monocular distance corrected near visual acuity (DCNVA) when measured at 40cm at 6 month visit among subjects implanted with the HOYA Vivinex™
Gemetric™ Plus Toric preloaded IOLs will be non-inferior to that of subjects implanted with the Alcon Acrysof® IQ PanOptix® Toric Trifocal IOLs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132442 0
Dr Michael Shiu
Address 132442 0
Cataract & Eye Surgery Centre. Suite 7, Level 1, 860 Doncaster Rd, Doncaster East, VIC 3109, Australia
Country 132442 0
Australia
Phone 132442 0
+61 3 8802 8600
Fax 132442 0
Email 132442 0
[email protected]
Contact person for public queries
Name 132443 0
Esther Chu
Address 132443 0
HOYA Medical Singapore Pte. Ltd., 10 Biopolis Road, #04-01/06, Chromos, 138670
Country 132443 0
Singapore
Phone 132443 0
+65 9751388
Fax 132443 0
Email 132443 0
[email protected]
Contact person for scientific queries
Name 132444 0
Esther Chu
Address 132444 0
HOYA Medical Singapore Pte. Ltd., 10 Biopolis Road, #04-01/06, Chromos, 138670
Country 132444 0
Singapore
Phone 132444 0
+65 9751388
Fax 132444 0
Email 132444 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?

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.