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Trial details imported from

For full trial details, please see the original record at

Trial ID
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study
Scientific title
Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphakia 0 0
Cataract 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Study type
Description of intervention(s) / exposure
Treatment: Devices - Study IOL
Treatment: Devices - Hoya iSert 751
Treatment: Devices - Negatively aspheric IOL

Experimental: Both Eyes - Model 751 IOL implanted in both eyes.

Experimental: Single eye - Model 751 IOL in one eye

Active Comparator: Control - Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent

Treatment: Devices: Study IOL
Aspheric IOL for correction of aphakia

Treatment: Devices: Hoya iSert 751
Model 751 in one eye, standard IOL in other eye

Treatment: Devices: Negatively aspheric IOL
Negatively aspheric IOL in both eyes

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near
Timepoint [1] 0 0
Up to 3 months

Key inclusion criteria
- Senile cataract

- Patient identified as a candidate for cataract surgery and IOL implantation

- Willing to sign informed consent document approved by the Ethical Committee

- Willing to complete all required tests and exams per this protocol
Minimum age
40 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Amblyopia

- History or evidence of any ocular disease that may affect visual acuity

- Previous ocular surgery, including refraction surgery

- Ocular anomalies (e.g. microphthalmos, kerataconous)

- Subjects with greater than 1.0 D of corneal astigmatism

- Subjects who experience intraoperative complications that could affect postoperative
IOL centration or tilt

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

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

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Hoya Surgical Optics, Inc.

Ethics approval
Ethics application status

Brief summary
To evaluate visual acuity and quality of vision in participants undergoing cataract surgery
with a Hoya model 751 intra-ocular lens and to compare the visual results to the common
monofocal lens in use.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Graham Barrett, MD
Address 0 0
Sir Charles Gairdner Hospital, Nedlans WA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries