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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01544777




Registration number
NCT01544777
Ethics application status
Date submitted
21/02/2012
Date registered
6/03/2012
Date last updated
25/03/2015

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
DOF-1
Universal Trial Number (UTN)
Trial acronym
751
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

Intervention/exposure
Study type
Interventional
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

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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Factorial
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
WA
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
Name
Hoya Surgical Optics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/study/NCT01544777
Trial related presentations / publications
Public notes

Contacts
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01544777