Visual AcuityNCT01191502
Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence
An observational study of Visual Acuity, run by Innovative Medical at 1 site in United States.
Trial summary
The purpose of this study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 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: Evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
Who may be able to join
- 18 years of age or older
- Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ HD Accommodating IOL
- Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Who cannot join
- Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
- Use of systemic or ocular medications that may affect visual outcomes
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma
- History of ocular surgery other than that required for inclusion in this study
Show all 12Show fewer
- Amblyopia or strabismus
- Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
- Subjects who may be expected to require retinal laser treatment or other surgical intervention
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Sciences University
Eugene, Oregon, 97401
About this study
Official title: Comparative Study of Photopic and Mesopic Distance Intermediate and Near Visual Acuity, and Spectacle Independence With Binocular Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens HD (CHD) Intraocular Lens
The purpose of this study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
- Conditions
- Visual Acuity
- Keywords
- Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
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 |
|---|---|---|
| TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS | Not described | |
| CRYSTALENS HD (CHD) INTRAOCULAR LENS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manifest refraction (monocular)
Measured: 1 year
Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
Measured: 1 year
Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
Measured: 1 year
Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
Measured: 1 year
Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
Measured: 1 year
Photopic and mesopic pupillometry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Medical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191502
- Sponsor's protocol ID
- TMF-09-002
- Status last verified
- Oct 2011
- First submitted
- 27 Aug 2010
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Photopic and Mesopic Distance Intermediate and Near Visual Acuity, and Spectacle Independence With Binocular Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens HD (CHD) Intraocular Lens
- ClinicalTrials.gov ID
- NCT01191502
- Acronym / sponsor ID
- TMF-09-002
- Conditions
- Visual Acuity
- Keywords
- Patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Innovative MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Aug 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 study is to evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECNIS MULTIFOCAL (TMF) INTRAOCULAR LENS | – | – |
| CRYSTALENS HD (CHD) INTRAOCULAR LENS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Evaluate visual acuity in different lighting conditions (daylight and night time) and distances (distance, near and intermediate), and the independence of glasses, in patients who have had binocular implantation of the Tecnis Multifocal IOL or the Crystalens™ HD Accommodating IOL.
Key inclusion criteria (6 listed)
- 18 years of age or older
- Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ HD Accommodating IOL
- Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
- Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
Key exclusion criteria (12 listed)
- Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
- Use of systemic or ocular medications that may affect visual outcomes
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma
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
Manifest refraction (monocular)
Time frame: 1 year
Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
Time frame: 1 year
Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in photopic lighting (monocular and binocular)
Time frame: 1 year
Uncorrected visual acuity (UCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
Time frame: 1 year
Best distance-corrected visual acuity (BDCVA) ETDRS testing at distance, intermediate and near in mesopic lighting (monocular and binocular)
Time frame: 1 year
Photopic and mesopic pupillometry
Time frame: 1 year
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 6 Oct 2011.
Related trials for Visual Acuity
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
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?
An observational study of Visual Acuity, 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 6 inclusion and 12 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 6 Oct 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?
Manifest refraction (monocular) (time frame: 1 year). The study lists 6 primary outcomes in all. 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 6 Oct 2011.