Aphakia751NCT01544777
Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study
A study testing Study IOL, Hoya iSert 751 and Negatively aspheric IOL in people with Aphakia and Cataract, run by Hoya Surgical Optics, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- What is being tested?
- Study IOL, Hoya iSert 751 and Negatively aspheric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
About this study
Official title: Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study
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.
- Being tested
- Study IOL, Hoya iSert 751, Negatively aspheric IOL
- Keywords
- Aphakia, Cataract
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study IOLDevice
Also called Hoya iSert 751 IOL
Aspheric IOL for correction of aphakia
Hoya iSert 751Device
Also called Hoya iSert Model 751
Model 751 in one eye, standard IOL in other eye
Negatively aspheric IOLDevice
Also called Hoya iSert model 251 or equivalent
Negatively aspheric IOL in both eyes
| Study group | Role | What they receive |
|---|---|---|
| Both Eyes | Experimental | Model 751 IOL implanted in both eyes. Receives: Device: Study IOL |
| Single eye | Experimental | Model 751 IOL in one eye Receives: Device: Hoya iSert 751 |
| Control | Active comparator | Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent Receives: Device: Negatively aspheric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoya Surgical Optics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graham Barrett, MD, Principal investigator, Sir Charles Gairdner Hospital, Nedlans WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544777
- Sponsor's protocol ID
- DOF-1
- Acronym
- 751
- Status last verified
- Aug 2012
- First submitted
- 21 Feb 2012
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT01544777
- Acronym / sponsor ID
- 751 / DOF-1
- Keywords
- Aphakia, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hoya Surgical Optics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Both Eyes | Experimental | Device: Study IOLModel 751 IOL implanted in both eyes. |
| Single eye | Experimental | Device: Hoya iSert 751Model 751 IOL in one eye |
| Control | Active comparator | Device: Negatively aspheric IOLAphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study IOLAlso: Hoya iSert 751 IOLAspheric IOL for correction of aphakia | Device | Both Eyes |
| Hoya iSert 751Also: Hoya iSert Model 751Model 751 in one eye, standard IOL in other eye | Device | Single eye |
| Negatively aspheric IOLAlso: Hoya iSert model 251 or equivalentNegatively aspheric IOL in both eyes | Device | Control |
Primary outcome
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Barrett, MD principal investigator
Sir Charles Gairdner Hospital, Nedlans WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study IOL, Hoya iSert 751 and Negatively aspheric IOL in people with Aphakia and Cataract, run by Hoya Surgical Optics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.