Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001189718
Ethics application status
Approved
Date submitted
10/10/2013
Date registered
29/10/2013
Date last updated
21/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Investigation of the Extended Range of Vision (ERV) Intraocular Lenses (IOLs), Model XRA03 and Toric Series ZXT in Participants Requiring Bilateral Cataract Removal and Lens Replacement.
Scientific title
Prospective, Non-randomized, Multicenter, Parallel group (55-75 subjects) Clinical Investigation of Extended Range of Vision (ERV) Intraocular Lenses, XRA03 and Toric series ZXT on Best-Corrected Distance Visual Acuity in Participants Requiring Bilateral Cataract Removal and Lens Replacement Sequentially In Both Eyes
.
Secondary ID [1] 283247 0
Nil
Universal Trial Number (UTN)
UTN1111-1148-5637
Trial acronym
EROV-107-ZXRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bilateral Cataract removal and replacment of crystalline lens with an investigational extended range of vision IOL, in otherwise healthy eyes 290119 0
Condition category
Condition code
Eye 290502 290502 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigational Toric ERV Intraocular lens (IOL). This model series ZXT is a modification from the currently marketed Tecnis Toric IOL with the same toric options in a range of 1.50 D – 4.00 D. The spherical diffractive posterior surface of the Toric lens optic has been designed to provide an increased range of vision (far, intermediate and near) and a reduction in residual refractive cylinder. The eye will be marked preoperatively for a standard axis orientation for toric lens placement, the cataractous lens will be removed during a routine phacoemulsification procedure lasting approximately 30 mins, and the toric lens will be implanted using the preoperative marks as guidelines. Once implanted using an Abbott lens inserter/unfolder, the design benefits of the lens are intended to be permanent.
Intervention code [1] 287976 0
Treatment: Devices
Comparator / control treatment
Investigational non-toric ERV IOL, Model XRA03. In this model a modification from the currently marketed multi-focal lens, the spherical diffractive posterior surface of the lens optic has been designed to provide an increased range of vision (far, intermediate and near) and to partially correct for chromatic aberrations. The cataractous lens will be removed by routine phacoemulsification procedure lasting approximately 30 mins. Once implanted using an Abbott lens inserter/unfolder, the design benefits of the lens are intended to be permanent.
Control group
Active

Outcomes
Primary outcome [1] 290524 0
Monocular, photopic, best-corrected distance visual acuity at six months for the ERV model series ZXT IOL compared to that for the ERV model XRA03.
Subjects will be tested monocularly per standardized visual acuity methods using ETDRS eye charts situated at a specific distance under controlled lighting conditions.
Timepoint [1] 290524 0
Six months
Secondary outcome [1] 304720 0
Monocular , photopic, distance-corrected intermediate visual acuity at 66 cm for the ERV series ZXT IOLs compared to that for the XRA03 lens.

Subjects will be tested monocularly per standardized visual acuity methods using ETDRS eye charts situated at a intermediate distance (66cm) under controlled lighting conditions.
Timepoint [1] 304720 0
Six months
Secondary outcome [2] 304721 0
Monocular, photopic, uncorrected distance visual acuity for the ERV series ZXT IOLs compared to that for the XRA03 lens.

Subjects will be tested monocularly per standardized visual acuity methods using ETDRS eye charts situated at a distance under controlled lighting conditions .
Timepoint [2] 304721 0
Six months
Secondary outcome [3] 304722 0
A unique Sponsor-developed questionnaire for this study addressing spectacle independence and subject satisfaction (including dysphotopsia) will be completed by participants. (descriptive purposes only)
Timepoint [3] 304722 0
Six months

Eligibility
Key inclusion criteria
1. Bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation are planned
2. Visual potential of 6/7.5 Metric (20/25 Snellen) or better in each eye following cataract removal and IOL implantation
3. Clear intraocular media other than cataract in each eye
4. Normal corneal topography

5. Subjects for ERV Model Series ZXT only:
5.1 Preoperative corneal cylinder between 0.75 D and 3.62 D in both eyes and an AMO Toric calculation lens model recommendation of a ZCT lens equal to the study lens powers of ZXT150, ZXT225, ZXT300, or ZXT375, with a predicted spherical equivalent outcome of emmetropia (+/-0.25 D).
Minimum age
20 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
2. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
4.Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses
5. Use of systemic or ocular medications that may affect vision
6. No irregular corneal astigmatism.
7. Poorly-controlled diabetes
8. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment via recommendation by PI/CI surgeons based on pre surgery assessment of subject against the acceptance critieria after informed consent given. Detailed information of the potential risks and benefits to participation in this clinical study is discussed with each subject as detailed on the informed consent form. Allocation of a toric or non-toric ERV lens will depend on subject's preoperative biometry and astigmatism.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomized
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the Primary (BCDVA) and Secondary Endpoints (DCIVA, UCDVA), there is more than a 89% power for equivalence testing to detect a difference in mean visual acuity between IOL groups (assume no difference in groups, standard deviation of 1.2 lines, equivalence margin of 1 line, and a two-sided significance level of 0.05) with 40 subjects in the Toric Study Lens group and 25 subjects in the Study Lens group.
For the Other endpoints, descriptive statistics including mean, standard deviation, minimum and maximum values will be reported for continuous variables. The frequency and proportion will be reported for categorical variables.

BCDVA= Best-corrected distance visual acuity
DCIVA = Distance-corrected intermediate visual acuity
UCDVA= Uncorrected distance visual acuity

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/04/2014
Actual
14/04/2014
Date of last participant enrolment
Anticipated
14/06/2015
Actual
10/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 5420 0
New Zealand
State/province [1] 5420 0

Funding & Sponsors
Funding source category [1] 287987 0
Commercial sector/Industry
Name [1] 287987 0
Abbott Medical Optics Inc
Country [1] 287987 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Optics Inc
Address
1700 East Saint Andrew Place
Santa Ana,
California 92705
Country
United States of America
Secondary sponsor category [1] 286706 0
None
Name [1] 286706 0
Address [1] 286706 0
Country [1] 286706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289915 0
Southern Health and Disability Ehtics Committee (HDEC) New Zealand
Ethics committee address [1] 289915 0
C/- MEDSAFE, Lvl 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
New Zealand
Ethics committee country [1] 289915 0
New Zealand
Date submitted for ethics approval [1] 289915 0
13/11/2013
Approval date [1] 289915 0
24/02/2014
Ethics approval number [1] 289915 0

Summary
Brief summary
The study objective is to evaluate the clinical outcomes of far, intermediate and near visual acuity and the rates of complications and adverse events in subjects implanted with the ERV Model XRA03 IOL and the ERV Toric IOL, Model Series ZXT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43062 0
Dr Dean Corbett BSc MBChB, FRANZCO
Address 43062 0
Auckland Eye
8 St Mark's Road
Remuera
1050 Auckland
Country 43062 0
New Zealand
Phone 43062 0
+64 9 529 24780
Fax 43062 0
+64 9 529 24781
Email 43062 0
[email protected]
Contact person for public queries
Name 43063 0
Dr Dean Corbett BSc MBChB, FRANZCO
Address 43063 0
Auckland Eye
8 St Mark's Road
Remuera
1050 Auckland
Country 43063 0
New Zealand
Phone 43063 0
+64 9 529 24780
Fax 43063 0
+64 9 529 24781
Email 43063 0
[email protected]
Contact person for scientific queries
Name 43064 0
Ms Anne Buteyn
Address 43064 0
Abbott Medical Optics Inc.
543 Ohio Ave
Oostburg, WI 53070
Country 43064 0
United States of America
Phone 43064 0
+1 949-505-2029
Fax 43064 0
+1 714-247-4610
Email 43064 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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