AphakiaHMYNCT00625313
Clinical Study of a UV-Absorbing Acrylic Posterior Chamber Intraocular Lens
A study testing HMY Model YA-60BB IOL in people with Aphakia, run by Hoya Surgical Optics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the optical correction of aphakia following cataract extraction. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphakia
- What is being tested?
- HMY Model YA-60BB IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 617 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Dec 2008
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with cataract who are eligible for phacoemulsification cataract extraction of the lens through an incision of approximately 4 mm, and primary implantation of a posterior chamber intraocular lens.
- Patients must have no pre-existing ocular conditions that preclude the ability of the treated eye to achieve BCVA of 20/40 or better after IOL implantation.
- Patients must be at least 21 years of age.
- Patients must sign a written informed consent form.
- Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.
Who cannot join
- Patients with a history of/or clinical signs of any of the following sight-threatening conditions:
- Previous Retinal Detachment or retinal pathology in operative eye, only
- Macular Degeneration in either eye
- Macular Edema in either eye
- Persistent Iritis/Uveitis in operative eye, only
- Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
Show all 14Show fewer
- Significant Corneal Disease in operative eye, only
- Proliferative Diabetic Retinopathy in either eye
- Patients who have had previous ocular surgery, of any kind, within the last 6 months or patients who have had previous ocular surgery at any time and who do not have potential BCVA after cataract extraction/IOL implantation of 20/40 or better
- Patients who have best corrected vision worse than 20/200 in the fellow eye.
- Patients with serious (i.e., life threatening) non-ophthalmic disease which may preclude study completion.
- Patients who have undergone previous cataract extraction and intraocular lens implantation.
- Patients unwilling or unable to sign the IRB-approved informed consent document for the study or who cannot or will not complete the study's examination schedule.
- Patients who are currently enrolled in another clinical trial, or who exited a clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Hoya Surgical Optics, Inc. for Trial Locations
Chino Hills, California, 91709
About this study
Official title: A Prospective, Multi-center, Single-phase, Non-randomized, Open-label Study to Assess the Safety and Efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) for the Correction of Aphakia Following Phacoemulsification Cataract Extraction
The purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the optical correction of aphakia following cataract extraction.
Read the detailed description
A prospective, single-phase, non-randomized, open-label study to include patients with operable cataract of the human crystalline lens who have a potential post-operative best corrected visual acuity of 20/40 or better and no pre-existing progressive sight-threatening ocular disorders. Patients who are eligible per inclusion / exclusion criteria will undergo phacoemulsification cataract extraction and then implantation of the Hoya HMY Model YA-60BB posterior chamber intraocular lens. Each patient will be followed-up at specific time intervals to assess safety and effectiveness, for up to 36 months.
- Conditions
- Aphakia
- Being tested
- HMY Model YA-60BB IOL
- Keywords
- Cataract, aphakia, intraocular lens, IOL, Optical correction of aphakia
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMY Model YA-60BB IOLDevice
Also called Hoya HMY Acrylic Foldable Intraocular Lens
Following phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed.
| Study group | Role | What they receive |
|---|---|---|
| HMY Model YA-60BB IOL | Experimental | Patients receiving a Hoya HMY Acrylic Foldable Intraocular Lens. Receives: Device: HMY Model YA-60BB IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Measured: 12 months postoperative
Secondary outcomes (1)
Adverse events/complications
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startMar 2004
- Primary completionDec 2008
- Study completionDec 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoya Surgical Optics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven L. Ziemba, M. Sc, Study chair, Hoya Surgical Optics / Fullerton Regulatory & Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625313
- Sponsor's protocol ID
- HSO 2003-A101
- Acronym
- HMY
- Status last verified
- Aug 2015
- First submitted
- 19 Feb 2008
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-phase, Non-randomized, Open-label Study to Assess the Safety and Efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) for the Correction of Aphakia Following Phacoemulsification Cataract Extraction
- ClinicalTrials.gov ID
- NCT00625313
- Acronym / sponsor ID
- HMY / HSO 2003-A101
- Conditions
- Aphakia
- Keywords
- Cataract, aphakia, intraocular lens, IOL, Optical correction of aphakia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Hoya Surgical Optics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Feb 2008 (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 purpose of this study is to assess the safety and efficacy of the HMY Model YA-60BB Intraocular Lens (IOL) when implanted in the posterior chamber of the human eye for the optical correction of aphakia following cataract extraction.
Detailed description
A prospective, single-phase, non-randomized, open-label study to include patients with operable cataract of the human crystalline lens who have a potential post-operative best corrected visual acuity of 20/40 or better and no pre-existing progressive sight-threatening ocular disorders. Patients who are eligible per inclusion / exclusion criteria will undergo phacoemulsification cataract extraction and then implantation of the Hoya HMY Model YA-60BB posterior chamber intraocular lens. Each patient will be followed-up at specific time intervals to assess safety and effectiveness, for up to 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMY Model YA-60BB IOL | Experimental | Device: HMY Model YA-60BB IOLPatients receiving a Hoya HMY Acrylic Foldable Intraocular Lens. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with cataract who are eligible for phacoemulsification cataract extraction of the lens through an incision of approximately 4 mm, and primary implantation of a posterior chamber intraocular lens.
- Patients must have no pre-existing ocular conditions that preclude the ability of the treated eye to achieve BCVA of 20/40 or better after IOL implantation.
- Patients must be at least 21 years of age.
- Patients must sign a written informed consent form.
- Patients must be able and willing to return for scheduled follow-up examinations after surgery throughout the 36 month study.
Key exclusion criteria (14 listed)
- Patients with a history of/or clinical signs of any of the following sight-threatening conditions:
- Uncontrolled Glaucoma or under current treatment for glaucoma in either eye
- Significant Corneal Disease in operative eye, only
- Proliferative Diabetic Retinopathy in either eye
- Patients who have had previous ocular surgery, of any kind, within the last 6 months or patients who have had previous ocular surgery at any time and who do not have potential BCVA after cataract extraction/IOL implantation of 20/40 or better
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 |
|---|---|---|
| HMY Model YA-60BB IOLAlso: Hoya HMY Acrylic Foldable Intraocular LensFollowing phacoemulsification cataract extraction, insertion of a Hoya HMY posterior chamber intraocular lens will be performed. | Device | HMY Model YA-60BB IOL |
Primary outcome
Best Corrected Visual Acuity
Time frame: 12 months postoperative
1 secondary outcome
Adverse events/complications
Time frame: 12 months postoperative
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 2 Oct 2026.
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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.
Steven L. Ziemba, M. Sc study chair
Hoya Surgical Optics / Fullerton Regulatory & Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMY Model YA-60BB IOL in people with Aphakia, run by Hoya Surgical Optics, Inc. 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 5 inclusion and 14 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 2 Oct 2026. 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.
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?
Best Corrected Visual Acuity (time frame: 12 months postoperative). 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 2 Oct 2026.