CataractNCT02863159
A Clinical Assessment of the Full Range of Functional Vision With Three Tecnis Multifocal IOL 1-Piece Models in Bilateral Cataract Extraction
A study testing Tecnis Multifocal 1-Piece IOL in people with Cataract, run by Dell Laser Consultants at 1 site in United States.
Trial summary
The objective of this study is to evaluate the uncorrected binocular distance, intermediate, and near visual acuities, and assess patient's spectacle independence and satisfaction in individuals undergoing bilateral cataract extraction that have received two different arms of near add design IOLs of the same… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Tecnis Multifocal 1-Piece IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A patient with bilateral cataracts for which phacoemulsification extraction and a posterior multifocal IOL implantation has been planned for both eyes.
- Male or female in good general health, 21 years of age or older at the time of the pre-operative examination and willing to have surgery on their second eye within 7 to 30 days of their first eye.
- A patient must be willing to comply with study instructions, agree to make all office appointments, and complete the entire course of the study.
- A patient has the visual potential of 20/32 or better in each eye after cataract removal and IOL implantation in the judgment of the investigator.
- A patient with a preoperative corneal astigmatism of ≤ 1.5D in each eye [intraoperative management of corneal astigmatism is permissible, and may include arcuate incision(s) or LRI(s).]
- A patient has a post-operative astigmatism target of ≤ 0.5D in each eye.
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- A patient with clear ocular media other than cataract in each eye.
- A patient with normal OCT of the macula in each eye or a macula judged to be normal by the investigator by clinical examination.
- A patient with naturally dilated pupil sizes of > 3.5mm, evaluated under mesopic illumination.
- A patient must be able to read, comprehend and be willing to give HIPAA and Informed Consent.
Who cannot join
- A patient with a known pathology that may affect visual acuity (as determined by the investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in either eye.
- A patient with amblyopia or strabismus.
- A patient with capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) in either eye.
- A patient with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate as least 3.5mm under mesopic/scotopic conditions) in either eye.
- A patient with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp examination in either eye.
- A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye.
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- A patient with a history of ocular trauma, or ocular surgery in either eye.
- A patient that may, or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period in either eye.
- A patient that had refractive surgery (LASIK, LASEK, RK, PRK, etc.) prior to cataract surgery in either eye.
- A patient with a history of wearing PMMA lenses within 6 months, gas permeable lenses within one month, or extended wear daily soft contact lenses within seven days of their scheduled surgery.
- A patient that requires the use of systemic or ocular medications that may affect vision.
- A patient with an uncontrolled acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes, immunocompromised, etc.).
- A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A patient currently participating or who has participated within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dell Laser Consultants
Austin, Texas, 78746
Melissa Ciccarelli, 512-347-0255, mciccarelli@dellvision.com
Marga Lee, 512-347-0255, marga@dellvision.com
About this study
Official title: A Clinical Assessment of the Full Range of Functional Vision (Distance, Intermediate, Near) With Three Tecnis Multifocal IOL 1-Piece Models [+2.75D (ZKB00), +3.25D (ZLB00), +4.00D (ZMB00)] in Subjects Undergoing Bilateral Cataract Extraction
The objective of this study is to evaluate the uncorrected binocular distance, intermediate, and near visual acuities, and assess patient's spectacle independence and satisfaction in individuals undergoing bilateral cataract extraction that have received two different arms of near add design IOLs of the same diffractive multifocal model.
Read the detailed description
This will be a multi-center, parallel comparison clinical study design with two treatment groups. One hundred (100) qualified study patients will receive a +2.75D (ZKB00) Tecnis Multifocal 1-Piece IOL in their dominant eye. Of these study patients, 50 patients will receive the +3.25D (ZLB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye and the other 50 patients will receive the +4.00D (ZMB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye. each study patient will undergo the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the first eye. In addition, as is customary for the surgeon, each study patient will receive the same open-label pre-operative, operative and post-operative medications over the course of the study period.
- Conditions
- Cataract
- Being tested
- Tecnis Multifocal 1-Piece IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis Multifocal 1-Piece IOLDevice
+2.75D (ZKB00), +3.25D (ZKB00), +4.00D (ZMB00)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Active comparator | 50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +3.25D (ZLB00) in their non-dominant eye. Receives: Device: Tecnis Multifocal 1-Piece IOL |
| Treatment Group 2 | Active comparator | 50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +4.00D (ZMB00) in their non-dominant eye. Receives: Device: Tecnis Multifocal 1-Piece IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of uncorrected and best corrected visual acuities under mesopic illumination at distance, intermediate, and near using the ETDRS chart.
Uncorrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7cm, and 40.0 cm. Best-corrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7 cm, and 40.0 cm.
Measured: 90 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dell Laser Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Optics
- Responsible party
- Sponsor
- Investigators
- Steven J Dell, MD, Principal investigator, Dell Laser Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863159
- Sponsor's protocol ID
- SJDLA-2015-01
- Status last verified
- Aug 2016
- First submitted
- 8 Mar 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dell SJ. Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers. Clin Ophthalmol. 2020 Sep 29;14:2903-2911. doi: 10.2147/OPTH.S266120. eCollection 2020.
PubMed 33061276
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Assessment of the Full Range of Functional Vision (Distance, Intermediate, Near) With Three Tecnis Multifocal IOL 1-Piece Models [+2.75D (ZKB00), +3.25D (ZLB00), +4.00D (ZMB00)] in Subjects Undergoing Bilateral Cataract Extraction
- ClinicalTrials.gov ID
- NCT02863159
- Acronym / sponsor ID
- SJDLA-2015-01
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dell Laser ConsultantsUniversity, hospital or other
- Collaborators
- Abbott Medical Optics
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 11 Aug 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.
The objective of this study is to evaluate the uncorrected binocular distance, intermediate, and near visual acuities, and assess patient's spectacle independence and satisfaction in individuals undergoing bilateral cataract extraction that have received two different arms of near add design IOLs of the same diffractive multifocal model.
Detailed description
This will be a multi-center, parallel comparison clinical study design with two treatment groups. One hundred (100) qualified study patients will receive a +2.75D (ZKB00) Tecnis Multifocal 1-Piece IOL in their dominant eye. Of these study patients, 50 patients will receive the +3.25D (ZLB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye and the other 50 patients will receive the +4.00D (ZMB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye. each study patient will undergo the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the first eye. In addition, as is customary for the surgeon, each study patient will receive the same open-label pre-operative, operative and post-operative medications over the course of the study period.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Active comparator | Device: Tecnis Multifocal 1-Piece IOL50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +3.25D (ZLB00) in their non-dominant eye. |
| Treatment Group 2 | Active comparator | Device: Tecnis Multifocal 1-Piece IOL50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +4.00D (ZMB00) in their non-dominant eye. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A patient with bilateral cataracts for which phacoemulsification extraction and a posterior multifocal IOL implantation has been planned for both eyes.
- Male or female in good general health, 21 years of age or older at the time of the pre-operative examination and willing to have surgery on their second eye within 7 to 30 days of their first eye.
- A patient must be willing to comply with study instructions, agree to make all office appointments, and complete the entire course of the study.
- A patient has the visual potential of 20/32 or better in each eye after cataract removal and IOL implantation in the judgment of the investigator.
- A patient with a preoperative corneal astigmatism of ≤ 1.5D in each eye [intraoperative management of corneal astigmatism is permissible, and may include arcuate incision(s) or LRI(s).]
Key exclusion criteria (14 listed)
- A patient with a known pathology that may affect visual acuity (as determined by the investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in either eye.
- A patient with amblyopia or strabismus.
- A patient with capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) in either eye.
- A patient with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate as least 3.5mm under mesopic/scotopic conditions) in either eye.
- A patient with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp examination in either eye.
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 |
|---|---|---|
| Tecnis Multifocal 1-Piece IOL+2.75D (ZKB00), +3.25D (ZKB00), +4.00D (ZMB00) | Device | Treatment Group 1, Treatment Group 2 |
Primary outcome
Measurements of uncorrected and best corrected visual acuities under mesopic illumination at distance, intermediate, and near using the ETDRS chart.
Time frame: 90 days post-operative
Uncorrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7cm, and 40.0 cm. Best-corrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7 cm, and 40.0 cm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Derived from this study: PubMed 33061276Dell SJ. Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers. Clin Ophthalmol. 2020 Sep 29;14:2903-2911. doi: 10.2147/OPTH.S266120. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Steven J Dell, MD principal investigator
Dell Laser Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecnis Multifocal 1-Piece IOL in people with Cataract, run by Dell Laser Consultants 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Ciccarelli (512-347-0255, mciccarelli@dellvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurements of uncorrected and best corrected visual acuities under mesopic illumination at distance, intermediate, and near using the ETDRS chart. (time frame: 90 days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02863159, which also lists 1 linked publication.
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 11 Aug 2016.