AphakiaNCT01292629
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
A study testing iSert 251 intraocular lens in people with Aphakia and Cataract, run by Hoya Surgical Optics, Inc. at 5 sites in United States.
Trial summary
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- iSert 251 intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2011to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- Have clear intraocular media
- Have potential Best Corrected Visual Acuity of 20/40 or better
- Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse
Who cannot join
- Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- Are monocular
- Have current ocular infection
- Are taking systemic steroids or other anti-metabolites
- Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study
- Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Katzen Eye Care and Laser Center
Boynton Beach, Florida, 33426
Eye Surgeons of Indiana
Indianapolis, Indiana, 46256
Center for Excellence in Eye Care
Miami, Florida, 33176
Eye Health Vision Centers
North Dartmouth, Massachusetts, 02747
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
About this study
Official title: Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
Read the detailed description
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
- Being tested
- iSert 251 intraocular lens
- Keywords
- intraocular lens, IOL, cataract, Hoya, surgical, optics, ocular, visual acuity
- Medical subject headings
- Aphakia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSert 251 intraocular lensDevice
aphakic intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Investigational intraocular lens | Experimental | iSert 251 intraocular lens Receives: Device: iSert 251 intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Measured: 4 to 6 months
Secondary outcomes (1)
Complications and Adverse Events
Number of Participants with Complications or Adverse Events
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoya Surgical Optics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kees den Besten, Study director, Hoya Surgical Optics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292629
- Sponsor's protocol ID
- 2010-N251
- Status last verified
- Mar 2015
- First submitted
- 4 Feb 2011
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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
- Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
- ClinicalTrials.gov ID
- NCT01292629
- Acronym / sponsor ID
- 2010-N251
- Keywords
- intraocular lens, IOL, cataract, Hoya, surgical, optics, ocular, visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Hoya Surgical Optics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 20 Mar 2015
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 multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
Detailed description
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational intraocular lens | Experimental | Device: iSert 251 intraocular lensiSert 251 intraocular lens |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- Have clear intraocular media
- Have potential Best Corrected Visual Acuity of 20/40 or better
- Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse
Key exclusion criteria (6 listed)
- Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- Are monocular
- Have current ocular infection
- Are taking systemic steroids or other anti-metabolites
- Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study
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 |
|---|---|---|
| iSert 251 intraocular lensaphakic intraocular lens | Device | Investigational intraocular lens |
Primary outcome
Visual Acuity
Time frame: 4 to 6 months
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
1 secondary outcome
Complications and Adverse Events
Time frame: 4 to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kees den Besten study director
Hoya Surgical Optics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSert 251 intraocular lens in people with Aphakia and Cataract, run by Hoya Surgical Optics, Inc. at 5 sites 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 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 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 5 sites 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?
Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Acuity (time frame: 4 to 6 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 2 Oct 2026.