Tilt and DecentrationNCT07324200
Objective Assessment of Intraocular Lens Tilt and Decentration
An observational study of Tilt and Decentration, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in United States.
Trial summary
Prospective, multi-center, non-interventional, open label, randomized clinical study. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tilt and Decentration
- What is being tested?
- OCT Imaging Test
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2026to 26 Jun 2026
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to approximately 80 subjects (40 by site) will be enrolled to obtain data on approximately 72 subjects (36 per site) to account for approximately 10% screen failure rate. All efforts will be made to enroll approximately 36 subjects per pre-study IOL group (i.e. 18 per site per pre-study IOL type). Approximately in total 36 subjects (18 per site) will be examined for each of the following two pre-study IOL groups. * Group 1: TECNIS refractive non-toric IOL models * Group 2: TECNIS diffractive non-toric IOL models
Who may be able to join
- Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
- Appear capable and willing to adhere to the clinical protocol instructions.
- Be 22 years of age or older at the time of screening.
- Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
- At least three months postoperative in the eligible eye.
Who cannot join
- Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities.
- Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
- Have a history of corneal or intraocular surgery other than cataract surgery.
- Using ocular or systemic medications known to interact with dilation drops.
- Have a history of allergic reactions to dilation drops.
- Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
Show all 11Show fewer
- Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
- Have a mydriatic pupil diameter of less than 6 mm.
- Have participated in a clinical trial within 7 days prior to study enrollment.
- An employee (e.g., Investigator, Coordinator, or Technician) or immediate family member (including partner, child, parent, grandparent, grandchild, or sibling) of an employee of the clinical site or study sponsor.
- Currently pregnant or lactating.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Empire Eye & Laser Center
Bakersfield, California, 93309
Jones Eye Center
Sioux City, Iowa, 51104
About this study
Prospective, multi-center, non-interventional, open label, randomized clinical study.
Read the detailed description
The objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.
- Conditions
- Tilt and Decentration
- Being tested
- OCT Imaging Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT Imaging TestDiagnostic test
Also called Basic Science
The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.
| Study group | Role | What they receive |
|---|---|---|
| TECNIS refractive non-toric IOL models | The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive non-toric IOL models. Receives: Diagnostic Test: OCT Imaging Test | |
| TECNIS diffractive non-toric IOL models | The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS diffractive non-toric IOL models. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt.
The primary endpoints for this study will be:
- Magnitude of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis.
- Direction of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis.
- Magnitude of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis.
- Direction of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis.
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 posted7 Jan 2026
- Study start3 Mar 2026
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tilt and DecentrationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Surgical Vision Inc. Johnson and Johnson, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324200
- Sponsor's protocol ID
- MDEV113OCTI
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Intraocular Lens Tilt and Decentration
- ClinicalTrials.gov ID
- NCT07324200
- Acronym / sponsor ID
- MDEV113OCTI
- Conditions
- Tilt and Decentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 7 Jan 2026 (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.
Prospective, multi-center, non-interventional, open label, randomized clinical study.
Detailed description
The objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECNIS refractive non-toric IOL models | – | Diagnostic Test: OCT Imaging TestThe primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive non-toric IOL models. |
| TECNIS diffractive non-toric IOL models | – | –The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS diffractive non-toric IOL models. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to approximately 80 subjects (40 by site) will be enrolled to obtain data on approximately 72 subjects (36 per site) to account for approximately 10% screen failure rate. All efforts will be made to enroll approximately 36 subjects per pre-study IOL group (i.e. 18 per site per pre-study IOL type). Approximately in total 36 subjects (18 per site) will be examined for each of the following two pre-study IOL groups. * Group 1: TECNIS refractive non-toric IOL models * Group 2: TECNIS diffractive non-toric IOL models
Key inclusion criteria (5 listed)
- Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
- Appear capable and willing to adhere to the clinical protocol instructions.
- Be 22 years of age or older at the time of screening.
- Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
- At least three months postoperative in the eligible eye.
Key exclusion criteria (11 listed)
- Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities.
- Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
- Have a history of corneal or intraocular surgery other than cataract surgery.
- Using ocular or systemic medications known to interact with dilation drops.
- Have a history of allergic reactions to dilation drops.
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 |
|---|---|---|
| OCT Imaging TestAlso: Basic ScienceThe primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models. | Diagnostic test | TECNIS refractive non-toric IOL models |
Primary outcome
Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt.
Time frame: One study visit
The primary endpoints for this study will be: * Magnitude of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Magnitude of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis.
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 Aug 2026.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Related trials for Tilt and Decentration
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Comparison of Two Different Methods for Calculating Intraocular Lens Tilt and Decentration
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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.
Surgical Vision Inc. Johnson and Johnson study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tilt and Decentration, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites 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 5 inclusion and 11 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt. (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 Aug 2026.