CataractPhase 3NCT02888210
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
A Phase 3 study testing MD-15 Intraocular Lens in people with Cataract, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- MD-15 Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteJapan
- Study dates
- 3 Sep 2016to 22 Nov 2017
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who intend to undergo phacoemulsification cataract extraction
Who cannot join
- Patients who undergo secondary implantation
- Patients with vision loss induced by causes other than cataract
- Patients who the principal investigator/subinvestigator considers ineligible for enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes
- Conditions
- Cataract
- Being tested
- MD-15 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.
MD-15 Intraocular LensDevice
| Study group | Role | What they receive |
|---|---|---|
| MD-15 | Experimental | Investigational intraocular lens Receives: Device: MD-15 Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected visual acuity
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start3 Sep 2016
- Primary completion22 Nov 2017
- Study completion22 Nov 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888210
- Sponsor's protocol ID
- MD151508
- Status last verified
- Feb 2018
- First submitted
- 30 Aug 2016
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
- ClinicalTrials.gov ID
- NCT02888210
- Acronym / sponsor ID
- MD151508
- Conditions
- Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2016 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 2 Sep 2016 (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.
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MD-15 | Experimental | Device: MD-15 Intraocular LensInvestigational intraocular lens |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who intend to undergo phacoemulsification cataract extraction
Key exclusion criteria (3 listed)
- Patients who undergo secondary implantation
- Patients with vision loss induced by causes other than cataract
- Patients who the principal investigator/subinvestigator considers ineligible for enrollment
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 |
|---|---|---|
| MD-15 Intraocular Lens | Device | MD-15 |
Primary outcome
Corrected visual acuity
Time frame: Week 52
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 27 Feb 2018.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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 Phase 3 study testing MD-15 Intraocular Lens in people with Cataract, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
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 1 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 27 Feb 2018. 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 Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Corrected visual acuity (time frame: Week 52). 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 27 Feb 2018.