CataractsPhase 4NCT01382641
Show Improved Vision With the HOYA AF-1 Aspheric Intraocular Lens After Cataract Surgery
A Phase 4 study testing Hoya AF-1 IOL and Revital vision in people with Cataracts, run by Innovative Medical at 1 site in United States.
Trial summary
The doctors participating in this study are looking to show improved vision with the HOYA AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of Revital Vision (neuro-sensory testing) in providing the highest potential for improved vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataracts
- What is being tested?
- Hoya AF-1 IOL and Revital vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must desire to pursue some type of mono-vision fit, mono-vision lasik, or mono-vision cataract surgery with lens implant.
- Patients must be candidates for intraocular lens implantation for the correction of aphakia following extracapsular cataract extraction by phaco-emulsification.
- Patients must be candidates for bilateral implantation and desiring post-operative spectacle independence through targeted mono-vision.
- Patients must have less than 1.50 diopters of corneal astigmatism
- Patients must have the potential for best corrected visual acuity of 20/30 or better in each eye.
- Patients must have the mental capacity to cooperate when undergoing a detailed postoperative refractive examination.
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- Patients must be an adult.
- Patients must provide written informed consent for cataract surgery.
- Patients must be willing and able to return for scheduled follow-up examinations for a period of 3 months (post-second eye) post-operatively.
- Patients must be willing and able to provide feedback to various survey questions regarding overall satisfaction and ease of adaptation to mono-vision and range of vision, etc.
Who cannot join
- Patients with 1.50 diopters or more of corneal astigmatism
- Patients requiring a lens power less than 6 D or greater than 30 D
- Patients with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, corneal dystrophy or corneal degeneration, tear film deficiency, poor pupil dilation, etc.).
- Patients with uncontrolled glaucoma or who require current treatment for glaucoma, or with visual field loss as a result of glaucoma.
- Patients with retinal pathology or a history of retinal detachment.
- Patients with proliferative diabetic retinopathy, macular degeneration, or other degenerative visual disorders.
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- Patients with a history of previous ocular surgery including corneal refractive surgery.
- Patients with congenital bilateral cataracts.
- Patients with marked microphthalmos or aniridia.
- Patients who have only one functioning eye.
- Patients who do not have the potential for visual acuity of 20/30 or better in each eye.
- Patients lacking intact binocular vision.
- Patients who do not have an intact capsulorhexis and posterior capsular bag at the time of cataract removal and lens implantation.
- Patients who have incomplete or damaged zonules, or who have zonular rupture during cataract removal.
- Patients with pupils greater than 7mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery
The doctors participating in this study are looking to show improved vision with the HOYA AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of Revital Vision (neuro-sensory testing) in providing the highest potential for improved vision.
- Conditions
- Cataracts
- Being tested
- Hoya AF-1 IOL, Revital vision
- Keywords
- Cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hoya AF-1 IOLDevice
The patients will be assessed for three months
Revital visionDevice
The patients will be assessed for three months.
| Study group | Role | What they receive |
|---|---|---|
| Hoya AF-1 IOL | Other | Not described Receives: Device: Hoya AF-1 IOL |
| Revital Vision | Other | Not described Receives: Device: Revital vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Ocular Dominance
Measured: 3 months
Overall post surgical outcomes
Measured: 3 months
Secondary outcomes (1)
Measuring visual acuities
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382641
- Sponsor's protocol ID
- Hoya AF-1
- Status last verified
- Oct 2011
- First submitted
- 3 Jun 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Eye Dominance in the Selection of Patients Suitable for Treatment With Monovision After Cataract Surgery
- ClinicalTrials.gov ID
- NCT01382641
- Acronym / sponsor ID
- Hoya AF-1
- Conditions
- Cataracts
- Keywords
- Cataract surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 Jun 2011 (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.
The doctors participating in this study are looking to show improved vision with the HOYA AF-1 aspheric intraocular lens after cataract surgery. They will also study the use of Revital Vision (neuro-sensory testing) in providing the highest potential for improved vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hoya AF-1 IOL | Other | Device: Hoya AF-1 IOL |
| Revital Vision | Other | Device: Revital vision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must desire to pursue some type of mono-vision fit, mono-vision lasik, or mono-vision cataract surgery with lens implant.
- Patients must be candidates for intraocular lens implantation for the correction of aphakia following extracapsular cataract extraction by phaco-emulsification.
- Patients must be candidates for bilateral implantation and desiring post-operative spectacle independence through targeted mono-vision.
- Patients must have less than 1.50 diopters of corneal astigmatism
- Patients must have the potential for best corrected visual acuity of 20/30 or better in each eye.
Key exclusion criteria (15 listed)
- Patients with 1.50 diopters or more of corneal astigmatism
- Patients requiring a lens power less than 6 D or greater than 30 D
- Patients with any anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, corneal dystrophy or corneal degeneration, tear film deficiency, poor pupil dilation, etc.).
- Patients with uncontrolled glaucoma or who require current treatment for glaucoma, or with visual field loss as a result of glaucoma.
- Patients with retinal pathology or a history of retinal detachment.
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 |
|---|---|---|
| Hoya AF-1 IOLThe patients will be assessed for three months | Device | Hoya AF-1 IOL |
| Revital visionThe patients will be assessed for three months. | Device | Revital Vision |
Primary outcome
Measuring Ocular Dominance
Time frame: 3 months
Overall post surgical outcomes
Time frame: 3 months
1 secondary outcome
Measuring visual acuities
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hoya AF-1 IOL and Revital vision in people with Cataracts, run by Innovative Medical at 1 site in United States.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Oct 2011. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Measuring Ocular Dominance (time frame: 3 months). The study lists 2 primary outcomes in all. 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 6 Oct 2011.