Cataract Surgery, Single-piece IOL, Microincisional IOLNCT07167589
Capsule Bag Performance of a Novel Single-piece Acrylic IOL HOYA AF-1 NY-60
A study testing Cataract surgery with implantation of a single-piece microincisional IOL in people with Cataract Surgery, Single-piece IOL, Microincisional IOL, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
During the past decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision, phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract Surgery, Single-piece IOL, Microincisional IOL
- What is being tested?
- Cataract surgery with implantation of a single-piece microincisional IOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2011to 1 Dec 2013
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age-related cataract
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Who cannot join
- Relevant other ophthalmic diseases especially those that may compromise capsule bag integrity or zonule stability (such as pseudoexfoliation syndrome, Marfan's syndrome, etc.)
- Preceding ocular surgery or trauma
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
About this study
During the past decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision, phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient.
In this study the capsule performance and stability of a new one-piece microincisional hydrophobic acrylic IOL (HOYA AF-1 NY-60) should be assessed in subgroups of normal, short and long eyes. The IOL has a sharp optic edge design to inhibit PCO formation. Hypothesis: The novel haptic design is supposed to avoid tension folds in capsule bag, allow for a longer contact length of haptic with capsule equator, ensure rotational stability as well as good centration of the optic.
- Being tested
- Cataract surgery with implantation of a single-piece microincisional IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgery with implantation of a single-piece microincisional IOLProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| HOYA acrylic single-piece IOL (HOYA AF-1 NY-60) | Other | Not described Receives: Procedure: Cataract surgery with implantation of a single-piece microincisional IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior chamber depth
Measured: 4 times, each 5 minutes during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Feb 2011
- Primary completion1 May 2013
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract Surgery, Single-piece IOL, Microincisional IOLStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167589
- Sponsor's protocol ID
- Viros_HOYA
- Status last verified
- Apr 2010
- First submitted
- 4 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Bag Performance of a Novel Single-piece Acrylic IOL HOYA AF-1 NY-60
- ClinicalTrials.gov ID
- NCT07167589
- Acronym / sponsor ID
- Viros_HOYA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 11 Sep 2025 (actual)
- 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.
During the past decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision, phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient.
In this study the capsule performance and stability of a new one-piece microincisional hydrophobic acrylic IOL (HOYA AF-1 NY-60) should be assessed in subgroups of normal, short and long eyes. The IOL has a sharp optic edge design to inhibit PCO formation. Hypothesis: The novel haptic design is supposed to avoid tension folds in capsule bag, allow for a longer contact length of haptic with capsule equator, ensure rotational stability as well as good centration of the optic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOYA acrylic single-piece IOL (HOYA AF-1 NY-60) | Other | Procedure: Cataract surgery with implantation of a single-piece microincisional IOL |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age-related cataract
- Age 21 and older
- Visual Acuity > 0.05
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (3 listed)
- Relevant other ophthalmic diseases especially those that may compromise capsule bag integrity or zonule stability (such as pseudoexfoliation syndrome, Marfan's syndrome, etc.)
- Preceding ocular surgery or trauma
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
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 |
|---|---|---|
| Cataract surgery with implantation of a single-piece microincisional IOL | Procedure or surgery | HOYA acrylic single-piece IOL (HOYA AF-1 NY-60) |
Primary outcome
Anterior chamber depth
Time frame: 4 times, each 5 minutes during procedure
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 23 Sep 2025.
- Individual participant dataSharing planned: Undecided
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 study testing Cataract surgery with implantation of a single-piece microincisional IOL in people with Cataract Surgery, Single-piece IOL, Microincisional IOL, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 3 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 23 Sep 2025. 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 Austria. 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?
Anterior chamber depth (time frame: 4 times, each 5 minutes during procedure). 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 23 Sep 2025.