Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000262707
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
5/03/2013
Date last updated
28/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Study of New Intraocular Lens Design in Participants requiring Bilaterial Cataract Removal
Scientific title
A Prospective, Non-randomised, Technician-masked, Parallel group (40-50 subjects), Dual site, Clinical Investigation of a new Intraocular Lens (model XRA03) when compared to the Control, Tecnis 1-piece Monofocal Lens (ZCB00) in participants requiring Bilaterial Cataract Removal to Assess Binocular Distance Vision Acuity and Incidence of Dysphotopsias.
Secondary ID [1] 281979 0
Nil
Universal Trial Number (UTN)
U111-1139-5832
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract extraction and artificial lens implantation for vision acuity restoration for far, intermediate and near vision with reduced need for further spectacle correction/dependence. 288408 0
Condition category
Condition code
Eye 288757 288757 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In Model XRA03, the spherical diffractive posterior surface of the lens optic has been modified to provide an increased range of vision and partially corrects for chromatic aberrations. After phacoemulsification/removal of a cataractous lens, the study device is implanted using a manual "Platinum 1" screw style Unfolder/handpiece through a minimally invasive (~2.4mm) corneal incision. A standard operative time is 30-40min. Once implanted, the design benefits are intended to be permanent.
Intervention code [1] 286551 0
Treatment: Devices
Comparator / control treatment
The control lenses are an approved monofocal hydrophobic acrylic Intraocular lens. Surgical approach for control device is identical to the study lens via phacoemulsification /extraction of the natural cataracterous lens followed by lens insertion through a minimally invasive (~2.4mm) corneal incision using a "Platinum1 " screw style Unfolder/ handpiece. A standard operative time is 30-40min.
Control group
Active

Outcomes
Primary outcome [1] 288896 0
Binocular range of vision. Subjects will read an eye chart situated at a various distances using both eyes.













Timepoint [1] 288896 0
Three months post-operative second lens implantation.
Secondary outcome [1] 301259 0
Sponsor developed Questionnaire assessment of patient satisfaction of vision quality, optical visual syptoms and spectacle usage administered by clinical staff.
Timepoint [1] 301259 0
Same as primary 3 months post operative second lens replacement.
Secondary outcome [2] 301260 0
Monocular and binocular uncorrected and best-corrected distance visual acuity. Subjects will read an eye chart situated at a far distance with and without spectacle correction using one eye at a time and both eyes.
Timepoint [2] 301260 0
Same as primary 3 months post operative second lens replacement.
Secondary outcome [3] 301261 0
Monocular and binocular distance-corrected intermediate visual acuity. Subjects will read an eye chart situated at an intermediate distance with correction using one eye at a time and both eyes.
Timepoint [3] 301261 0
Same as primary 3 months post operative second lens replacement.
Secondary outcome [4] 301262 0
Monocular and binocular distance corrected and best-corrected near visual acuity with minimum/threshold add. Subjects will read an eye chart situated at a near distance with correction using one eye at a time and both eyes. This will also be tested with correction that is equivalent to reading glasses.
Timepoint [4] 301262 0
Same as primary 3 months post operative second lens replacement.
Secondary outcome [5] 301263 0
Monocular best-corrected distance contrast sensitivity. Subjects will look at a contrast sensitivity eye chart (consisting of dark to light-colored lines) with correction and report what they see using one eye at a time.
Timepoint [5] 301263 0
Same as primary 3 months post operative second lens replacement.
Secondary outcome [6] 301264 0
Incidences of optical/ visual symptoms. Subjects will be asked whether they have experienced any specific types of visual symptoms and the observed intensity, if any since surgeries.
Timepoint [6] 301264 0
Same as primary 3 months post operative second lens replacement.

Eligibility
Key inclusion criteria
Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes

Visual potential of Decimal 0.8 (Snellen 20/25) or better in each eye after cataract removal and IOL implantation

Signed informed consent
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)

Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., uncontrolled, insulin-dependent diabetes, immunocompromised (including current or anticipated use of immunosuppressants), connective tissue disease, etc.)

Surgery that is not resolved/stable or may affect vision

Prior refractive surgery (LASIK, LASEK, RK, PRK, etc.)

Corneal abnormalities such as stromal, epithelial or endothelial dystrophies

Intraocular inflammation or recurrent ocular inflammatory condition

Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)

Capsule or zonule abnormalities that may affect postoperative IOL centration or tilt, including pseudoexfoliation, trauma, or surgical complications (e.g. zonular rupture, eccentric anterior capsulorhexis)

Requiring an intraocular study lens power outside the available range of +16.0 to +28.0 D

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 from PI/CI and meeting the acceptance criteria. Informed consent form provides detailed information on the potential benefits and risks associated with selection to participant in the trial.
Allocation of study lens not concealed. Subject can select to have the experimental lens implanted in both eyes.
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
Technician masked to prevent bias in post-operative measurements / lens performance. Investigator or designated trained clinician shall perform the biomicroscopic slit-lamp exam.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For visual acuity data, descriptive statistics will be the focus including mean, standard deviation (SD) and the 95% confidence intervals (C.I.) of the mean. All data will be reported by IOL group. Although some statistical comparisons will be performed between IOL groups, it is noted that statistical power is somewhat limited in this study due to the control group being small in size, thus the study focus is primarily to describe the performance of the study IOL. A statistical comparison between lens groups will also be performed using a one-sided, two-sample, t-test with an alpha set at 0.05. The null hypothesis is that the mean defocus range for Model XRA03 subjects is less than or equal to that for control subjects. For questionnaire data, the frequency and proportion of subjects with a given response will be reported by IOL group. For comparisons between IOL groups, for ordinal data, the Wilcoxon rank sum test will be used with the Fisher’s exact test used for categorical data. For questionnaire data two-sided testing will be used with alpha set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2013
Actual
13/05/2013
Date of last participant enrolment
Anticipated
16/06/2013
Actual
30/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4871 0
New Zealand
State/province [1] 4871 0
North Island

Funding & Sponsors
Funding source category [1] 286757 0
Commercial sector/Industry
Name [1] 286757 0
Abbott Medical Optics Inc
Country [1] 286757 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Optics Inc
Address
1700 E. Saint Andrew Place
Santa Ana,
California 92705
Country
United States of America
Secondary sponsor category [1] 285538 0
Individual
Name [1] 285538 0
Dr Dean Corbett BSc, MBChB, FRANZCO
Address [1] 285538 0
Auckland Eye
8 St. Marks Road
Remuera 1050
Auckland.
Country [1] 285538 0
New Zealand
Other collaborator category [1] 277293 0
Individual
Name [1] 277293 0
Dr Neil Murray
Address [1] 277293 0
71 Fairy Springs Road,
Rotorua 3010
New Zealand
Country [1] 277293 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288827 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 288827 0
Venue: Novetel Ellerslie
72-112 Greenlane Rd East
Auckland
Ethics committee country [1] 288827 0
New Zealand
Date submitted for ethics approval [1] 288827 0
28/02/2013
Approval date [1] 288827 0
23/04/2013
Ethics approval number [1] 288827 0
13/NTA/30

Summary
Brief summary
The purpose of this clinical trial is to evaluate the binocular clinical performance of a design modification to the Tecnis Monofocal IOL, Model XRA03. Results will include descriptive statistics on the visual performance of Model XRA03 in bilaterally implanted subjects (post phacoemulsification of cataracts) over distance, intermediate and near vision. This study is a prospective, non-randomized, technician-masked, parallel-group study of 40-50 subjects across up to two investigative sites. Clinical Hypothesis: The study IOL, Model XRA03 will achieve a mean binocular distance visual acuity of 20/40 or better at each defocus point through -1.5 diopters with minimal levels of clinically significant dysphotopsias (night glare/halos) and potentially provide improved uncorrected intermediate to near vision compared to currently marketed monofocal acrylic lenses.
Trial website
Trial related presentations / publications
1. Koretz J.F., Kaufman P.L, Neider M.W. Goeckner P.A. Accommodation and Presbyopia in the Human Eye – Aging of the Anterior Segment. Vision Res. 1989, Vol. 29, No. 12, pages 1685-1692.
2. Benjamin, William, J., Borish, Irvin M. Borish’s Clinical Refraction, Philadelphia: 1998, W.B. Saunders, pg 109.
Public notes
Results of this study will help determine the design for a larger clinical study that can support market approval and claims for Model XRA03 IOL.

Contacts
Principal investigator
Name 37950 0
Dr Dean Corbett BSc MBChB, FRANZCO
Address 37950 0
Auckland Eye
8 St. Mark's Road
Remuera 1050
Auckland.
Country 37950 0
New Zealand
Phone 37950 0
+64 9 529 2480
Fax 37950 0
+64 9 529 2481
Email 37950 0
[email protected]
Contact person for public queries
Name 37951 0
Dr Dean Corbett BSc MBChB, FRANZCO
Address 37951 0
Auckland Eye
8 St. Mark's Road
Remuera 1050
Auckland.
Country 37951 0
New Zealand
Phone 37951 0
+64 9 529 2480
Fax 37951 0
+64 9 529 2481
Email 37951 0
[email protected]
Contact person for scientific queries
Name 37952 0
Dr Eugenia Thomas
Address 37952 0
Senior Manager Clinical Research
Abbott Medical Optics Inc
1700 E. Saint Andrew Place
Santa Ana, California 92705
Country 37952 0
United States of America
Phone 37952 0
+1 (714) 247-8723
Fax 37952 0
+1 (714) 247-8784
Email 37952 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

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

Documents added automatically
No additional documents have been identified.