CataractNCT03247751
Evaluation of the Rotational Stability
A study testing intraocular lens in people with Cataract, run by Nidek Co. LTD..
Trial summary
To evaluate rotational stability of the investigational device implanted after cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 18 years or older
- Subject who diagnosed unilateral or bilateral age-related cataract.
- Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
- Calculated IOL power in within the range of investigational IOL.
- Subject is able to understand, agree and sign the informed consent statement.
- Subject is able and willing to comply with the postoperative follow-up examination schedule.
Who cannot join
- Uncontrolled systemic or ocular disease.
- Extremely shallow anterior chamber.
- Previous intraocular and corneal surgery.
- Traumatic cataract.
- Pregnancy or lactation.
- Concurrent participation in another drug and device clinical investigation.
About this study
Official title: Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens
To evaluate rotational stability of the investigational device implanted after cataract surgery.
Read the detailed description
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.
- Conditions
- Cataract
- Being tested
- intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraocular lensDevice
Implant NIDEK intraocular lens after cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| one group | Experimental | one group receiving NIDEK intraocular lens Receives: Device: intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intraocular lens rotation
The angle of the intraocular rotation.
Measured: postoperative 6 months
Secondary outcomes (2)
visual acuity
Distance BCVA
Measured: postoperative 6 months
Adverse event
severity and causal relationship
Measured: postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study startJun 2016
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247751
- Sponsor's protocol ID
- BPF001C
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2017
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens
- ClinicalTrials.gov ID
- NCT03247751
- Acronym / sponsor ID
- BPF001C
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Aug 2017 (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.
To evaluate rotational stability of the investigational device implanted after cataract surgery.
Detailed description
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group | Experimental | Device: intraocular lensone group receiving NIDEK intraocular lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults, 18 years or older
- Subject who diagnosed unilateral or bilateral age-related cataract.
- Potential postoperative BCVA of 0.2 log MAR (0.63) or better.
- Calculated IOL power in within the range of investigational IOL.
- Subject is able to understand, agree and sign the informed consent statement.
Key exclusion criteria (6 listed)
- Uncontrolled systemic or ocular disease.
- Extremely shallow anterior chamber.
- Previous intraocular and corneal surgery.
- Traumatic cataract.
- Pregnancy or lactation.
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 |
|---|---|---|
| intraocular lensImplant NIDEK intraocular lens after cataract surgery | Device | one group |
Primary outcome
The intraocular lens rotation
Time frame: postoperative 6 months
The angle of the intraocular rotation.
2 secondary outcomes
visual acuity
Time frame: postoperative 6 months
Adverse event
Time frame: postoperative 6 months
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 7 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing intraocular lens in people with Cataract, run by Nidek Co. LTD..
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 6 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The intraocular lens rotation (time frame: postoperative 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 7 Jun 2023.