PseudophakiaNCT01004549
An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses
An observational study of Pseudophakia, run by Innovative Medical at 1 site in United States.
Trial summary
This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudophakia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2011
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients age 18 and older
- Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:
- Crystalens
- Crysalens HD
- Tecnis One monofocal
- Patients must have a healthy cornea and macula
- Patients must have 20/25 or better best corrected vision
- Able to provide written informed consent
Who cannot join
- BCVA of less than 20/25
- On oral medications that could potentially block accommodation:
- First generation antihistamines
- Anticholinergic agents
- Anti-psychotic medications
- Antidepressant medications
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Excellence in Eye Care
Miami, Florida
About this study
This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.
- Conditions
- Pseudophakia
- Keywords
- Patients who have previously undergone bilateral intraocular lens implantation
- Medical subject headings
- Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral intraocular lens implantation. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading
Measured: one study visit
Secondary outcomes (1)
Amplitude of accommodation on pushdown test - and how it compares to the COAS test results
Measured: one study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudophakiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Trattler, MD, Principal investigator, The Center for Excellence in Eye Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004549
- Sponsor's protocol ID
- Accomodation study
- Status last verified
- Jun 2011
- First submitted
- 28 Oct 2009
- Last updated
- 28 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Evaluation of Degree of Accommodation in Pseudophakic Patients Bilaterally Implanted With Monofocal Intraocular Lenses
- ClinicalTrials.gov ID
- NCT01004549
- Acronym / sponsor ID
- Accomodation study
- Conditions
- Pseudophakia
- Keywords
- Patients who have previously undergone bilateral intraocular lens implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Oct 2009 (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.
This study will determine the ability of three different intraocular lenses to accommodate in patients who have previously undergone bilateral intraocular lens implantation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral intraocular lens implantation. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (8 listed)
- Patients age 18 and older
- Patients must have undergone cataract surgery and have bilateral implants of the same model. The models eligible for inclusion include:
- Patients must have a healthy cornea and macula
- Patients must have 20/25 or better best corrected vision
- Able to provide written informed consent
Key exclusion criteria (6 listed)
- BCVA of less than 20/25
- On oral medications that could potentially block accommodation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading
Time frame: one study visit
1 secondary outcome
Amplitude of accommodation on pushdown test - and how it compares to the COAS test results
Time frame: one study visit
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 28 Jun 2011.
Related trials for Pseudophakia
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Pseudophakia, Myopia
Enrolling by invitation
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
Pseudophakia, Myopia
Active, not recruiting
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Pseudophakia, Hypermetropia
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.
William Trattler, MD principal investigator
The Center for Excellence in Eye Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudophakia, run by Innovative Medical at 1 site 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 8 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 28 Jun 2011. 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 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 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?
Amplitude of accommodation on COAS and how it correlates with: spherical aberration on the COAS, pupil size at near as measured with COAS, spherical aberration on the topography, patient reported nead for spectacles for reading (time frame: one study visit). 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 28 Jun 2011.