AphakiaCOASTNCT01268540
Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
A study testing FY-60AD and NHT15, NHT30, & NHT53 in people with Aphakia and Cataract, run by Hoya Surgical Optics, Inc. at 6 sites in United States.
Trial summary
The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- FY-60AD and NHT15, NHT30, & NHT53
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2010to Jun 2014
- 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 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 at least one eye that meets the ranges of pre-operative corneal cylinder as specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after accounting for changes in corneal cylinder due to the incision)
- Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of a study lens
- Have clear intraocular media other than cataract
- Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or without a glare source
Who cannot join
- Have atonic pupils or physiologically small pupils in either eye (unable to dilate to at least 4 mm)
- Have irregular astigmatism in the operative eye, or refractive cylinder resulting only from lenticular astigmatism in the operative eye
- Have corneal pathology potentially affecting corneal topography, or other corneal abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- Have undergone previous refractive corneal surgery in the operative eye
- Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen, macular degeneration or other progressive retinal disorders) in the operative eye that are predicted to cause future visual acuity losses to a level of 20/30 or worse during the postoperative follow-up time requirements of this study
- Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Grosinger, Spigelman & Grey,
Bloomfield Hills, Michigan, 48302
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Contact Hoya Surgical Optics, Inc. for Trial Locations
Chino Hills, California, 91709
Silverstein Eye Conters
Dansas City, Missouri, 64133
Mid-Florida Eye Center
Mt. Dora, Florida, 32757
Shepard Eye Center
Santa Maria, California, 93454
About this study
The purpose of this multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.
- Being tested
- FY-60AD, NHT15, NHT30, & NHT53
- Keywords
- intraocular lens, IOL, cataract, refractive astigmatism, Aspheric, Toric, Hoya, Surgical, Optics, 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.
FY-60ADDevice
Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.
NHT15, NHT30, & NHT53Device
Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
| Study group | Role | What they receive |
|---|---|---|
| NHT15 | Experimental | Aspheric Toric Intraocular Lens Models NHT15 Receives: Device: NHT15, NHT30, & NHT53 |
| FY-60AD | Active comparator | Aspheric Non-toric Intraocular Lens: Model FY-60AD Receives: Device: FY-60AD |
| NHT30 | Experimental | Aspheric Toric Intraocular Lens Model NHT30 Receives: Device: NHT15, NHT30, & NHT53 |
| NHT53 | Experimental | Aspheric Toric Intraocular Lens Models NHT53 Receives: Device: NHT15, NHT30, & NHT53 |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent reduction of absolute cylinder
Measured: up to 14 months
Secondary outcomes (1)
Lens rotation or misalignment and patient satisfaction
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Rotational instability observed.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 235 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, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268540
- Sponsor's protocol ID
- 2010-T240
- Acronym
- COAST
- Status last verified
- Feb 2015
- First submitted
- 29 Dec 2010
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Aspheric Toric & Non-toric Aphakic Intraocular Lenses
- ClinicalTrials.gov ID
- NCT01268540
- Acronym / sponsor ID
- COAST / 2010-T240
- Keywords
- intraocular lens, IOL, cataract, refractive astigmatism, Aspheric, Toric, Hoya, Surgical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Rotational instability observed.
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Hoya Surgical Optics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Dec 2010 (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 multi-center clinical trial is to determine the safety and efficacy of the HSO Toric IOLs for the correction of aphakia and reduction of pre-existing refractive astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NHT15 | Experimental | Device: NHT15, NHT30, & NHT53Aspheric Toric Intraocular Lens Models NHT15 |
| FY-60AD | Active comparator | Device: FY-60ADAspheric Non-toric Intraocular Lens: Model FY-60AD |
| NHT30 | Experimental | Device: NHT15, NHT30, & NHT53Aspheric Toric Intraocular Lens Model NHT30 |
| NHT53 | Experimental | Device: NHT15, NHT30, & NHT53Aspheric Toric Intraocular Lens Models NHT53 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- Have at least one eye that meets the ranges of pre-operative corneal cylinder as specified by this study's guidelines, i.e. corneal cylinder of at least 1.0 D (after accounting for changes in corneal cylinder due to the incision)
- Have potential Best Corrected Visual Acuity of 20/30 or better after implantation of a study lens
- Have clear intraocular media other than cataract
- Have preoperative Best Corrected Visual Acuity equal to 20/40 or worse, with or without a glare source
Key exclusion criteria (6 listed)
- Have atonic pupils or physiologically small pupils in either eye (unable to dilate to at least 4 mm)
- Have irregular astigmatism in the operative eye, or refractive cylinder resulting only from lenticular astigmatism in the operative eye
- Have corneal pathology potentially affecting corneal topography, or other corneal abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- Have undergone previous refractive corneal surgery in the operative eye
- Have been diagnosed with any degenerative retinal disorders (e.g. soft drusen, macular degeneration or other progressive retinal disorders) in the operative eye that are predicted to cause future visual acuity losses to a level of 20/30 or worse during the postoperative follow-up time requirements of this 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 |
|---|---|---|
| FY-60ADPhacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD. | Device | FY-60AD |
| NHT15, NHT30, & NHT53Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53. | Device | NHT15, NHT30, NHT53 |
Primary outcome
percent reduction of absolute cylinder
Time frame: up to 14 months
1 secondary outcome
Lens rotation or misalignment and patient satisfaction
Time frame: up to 14 months
Results and safety
The study was stopped early (reason given: Rotational instability observed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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.
Kees den Besten study director
Hoya Surgical Optics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FY-60AD and NHT15, NHT30, & NHT53 in people with Aphakia and Cataract, run by Hoya Surgical Optics, Inc. at 6 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 5 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: stopped early, as of the sponsor's last update on 5 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 6 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?
The study was stopped early (reason given: Rotational instability observed.). 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?
percent reduction of absolute cylinder (time frame: up to 14 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 5 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.